Jobs That Crossed My Desk Through Sept
Jobs That Crossed My Desk Through Sept. 6, 2009
Contact the person whose information appears at the top of each listing. Listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines.
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Interested and qualified individuals please respond to rmohan@ and include CV.
EIR opportunity to head food tasting technology / device company
nBAC is a business acceleration firm that has focused on spinning out companies in the USA from European IP and inventions with a co-entrepreneurship model.
We are seeking an Entrepreneur In Residence to take on the Interim CEO role for one of our newly formed companies leading to permanent CEO or C level position. EIR/ interim position will include stipend/retainer during Phase-1 on accrual basis, to be paid in full upon initial funding. Also, C level salary & benefits + equity upon funding.
Our group has already performed a market validation study on this technology and we have several LOIs from major global food industry leaders interested in becoming customers.
Key Responsibilities:
- Business plan formation
- Spearheading the investment fund raising
- Bringing company to operational stage
Required Experience:
- Minimum ten years experience in the food related industry, with at least five years working with big food / agri industry, such as P&G, Pepsico, Kraft, etc., in a senior level.
- Involvement in investment fund raising.
Desired Additional Qualities:
- Direct fund raising experience.
- Contacts in the wine industry.
- Sales/Marketing & Entrepreneurship.
- Residence in Northern California.
Education:
- Minimum Bachelors degree. Higher degree such as MBA or graduate work in related areas are preferred.
NO RECRUITERS PLEASE!
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USES THE INTERNET TO CONDUCT TRADE SHOWS FOR THE PHARMACEUTICAL AND LIFE SCIENCE INDUSTRIES. BESIDES HAVING VIRTUAL EXHIBITS, WE ALSO HAVE A CLICK-BY-STATE JOB BULLETIN FOR BOTH EMPLOYERS/RECRUITERS AND JOB SEEKERS TO USE. THERE IS ONE NEW INTERESTING MARKETING POSITION:
Senior Marketing Manager - Austin, Tx
Please go to our job bulletin job and click on the state of interest or use our Advanced Search Functions to search for jobs. Please read the job descriptions carefully and follow the descriptions to apply.
We are also launching a new service called ePharmaCards – unique eCards with science and pharma themes. Pls be free to check them out.
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I AM HELPING A CLIENT FILL THIS POSTIION. THEY PREFER A FULL TIME HIRE BUT WOULD ALSO CONSIDER A CONSULTANT AVAILABLE AT LEAST 30 HR/WK AND 3 DAYS ON SITE. THEY ARE LOCATED NEAR SANTA CLARA.
PLEASE NOTE THAT TO QUALIFY FOR THIS POSITION, YOU MUST HAVE WORKED IN THE PHARMACEUTICAL INDUSTRY OR A CRO IN A SIMILAR POSITION FOR AT LEAST 1 YEAR.
JULIE WWW.
FOR MORE INFORMATION ON THIS POSITION, PLEASE CONTACT JULIE BUKAR AT JULIE@
(SENIOR) STATISTICAL ANALYTICAL SYSTEMS (SAS) PROGRAMMER
REPORTS TO VP, BIOSTATISTICS
LOCATION: NEAR SANTA CLARA, CA
PERFORM IN-HOUSE STATISTICAL PROGRAMMING, DATA MANAGEMENT AND ANALYSIS.
MAIN DUTIES AND RESPONSIBILITIES:
• MANAGEMENT OF DATABASE TRANSFER PROCESS AND DATABASE SPECIFICATIONS FOR VARIOUS PROJECTS IN COLLABORATION WITH OUTSIDE VENDORS FOR THE PURPOSE OF PROVIDING IN-HOUSE DATA MANAGEMENT AND ANALYSIS.
• WORK CLOSELY WITH CLINICAL GROUP AND OTHER INTERNAL STAFF AS A KEY TEAM MEMBER
• CREATION OF DERIVED DATA SPECIFICATIONS BASED ON STATISTICAL ANALYSIS PLAN.
• CREATION OF SAS PROGRAMS FOR CLINICAL TRIALS DATA SUMMARY AND ANALYSIS.
• PRODUCTION OF DERIVED DATA SETS FOR SAFETY AND EFFICACY.
• PRODUCTION AND SUMMARIZATION OF CLINICAL TRIALS DATA (TABLES, LISTINGS AND GRAPHICS).
• CREATION OF INTERNAL CAPABILITY TO MAINTAIN, SUMMARIZE, AND ANALYZE CLINICAL TRIALS DATA.
• PREPARATION OF STATISTICAL REGULATORY DOCUMENTS IN ANTICIPATION OF VARIOUS FDA/MAA SUBMISSIONS AND BRIEFING PACKAGES (EMINENT WORK).
JOB SPECIFICATIONS:
KNOWLEDGE/EDUCATION
• B.S. WITH M.S. OR PH.D. IN STATISTICS OR RELATED FIELD PREFERRED.
JOB EXPERIENCE
• AT LEAST 5 YEARS OF BIOPHARMACEUTICAL OR CRO EXPERIENCE (FOR SENIOR TITLE, AT LEAST 1 YEAR FOR SAS PROGRAMMER TITLE).
• REGULATORY SUBMISSION (NDA/BLA) EXPERIENCE.
• FLUENT IN SAS PROGRAMMING IS MANDATORY.
• FAMILIARITY WITH THE PREPARATION OF REGULATORY DOCUMENTS SUCH AS INTEGRATED SAFETY SUMMARY AND INTEGRATED SUMMARY OF EFFICACY IS REQUIRED.
SKILLS/COMPETENCIES
• EXCELLENT VERBAL AND WRITTEN COMMUNICATION SKILLS.
• COLLABORATIVE SKILLS IN TEAM SETTINGS ARE REQUIRED.
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IF YOU ARE INTERESTED IN LEARNING ABOUT BIOTECH JOB OPPORTUNITIES IN CHINA, THE MANAGEMENT TEAM OF KANGHONG PHARMACEUTICALS WILL HOST AN EVENT TO ANSWER YOUR QUESTIONS AND TO ATTRACT TALENTS FOR THEIR COMPANY. SEE THE FOLLOWING FOR THE EVENT DETAIL AND JOB OPENINGS AT KONGHONG. PLEASE EMAIL DR. MICHAEL YU AT MICH204@ IN ADVANCE IF YOU ARE INTERESTED IN ATTENDING THE EVENT.
1. Event: Kanghong Recruiting. A brief presentation about Pharmaceutical industry in China and Kanghong Pharmaceutical Group followed by a Q/A section on healthcare reform and pharmaceutical industry in China as well as our open positions in R&D and BD. We will help you in addressing questions such as why now is the good time to go back home and work in China.
2. Time: 2 PM to 5 PM, September 12, 2009 (Saturday).
3. Place: Conference Room Iris, Hilton Garden Inn, 2000 Bridgepointe Circle, San Mateo, CA 94404. Tel: 650-522-9000. Web:sanmateo. (next to Home Depot and Gilead Sciences)
4. Open positions: VP and Director level positions in the areas of Operations, Process Development (CHO based antibody production), Manufacturing, Quality, Medicinal Chemistry, Business Development, etc.
5. What should you do: if you plan to attend this event, please email Michael Yu at mich204@ in advance. Thanks.
Job Openings at Kanghong Pharmaceutical Group
Founded in 1994, Kanghong Pharmaceutical Group Co. Ltd. (Kanghong Pharma) is a modern pharmaceutical company focusing on the discovery, development and commercialization of pharmaceutical products for unmet medical needs. Currently our group has 2000 employees and eight products on market with annual revenue of 1.2 billion RMB in 2008. More information about Kanghong Pharma could be found at -.
Chengdu Kanghong Biotechnology Corporation Limited (Kanghong Biotech), a Kanghong Pharma’s subsidiary, is a Chengdu, China-based biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions. Kanghong Biotech currently has 143 employees with a subsidiary in Shanghai focusing on the discovery of antibody therapeutics and has therapeutic candidates in various development stages for the potential treatment of cancer, eye diseases, and inflammatory diseases. We are committed to creating value by building an accountable team, accelerating the development of lead product candidates, expanding our pipeline through internal discovery and in-licensing, and nurturing a unique company culture. Three products are currently in clinical trials while four products are in preclinical evaluation stage. Two GMP facilities with four production lines with bioreactors up to 1500 liters are being built. Kanghong Biotech has six granted patents and nine pending patents in China and filed seventeen PCT international patent applications.
Kanghong is currently recruiting experienced scientists and managers (including vice president and director levels) in the areas of process development, assay development, quality (QC/QA), facility engineer, manufacturing, medicinal chemistry and business development.
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SUPERGEN, HAS POSTED A CLINICAL PROGRAM MANAGER OPPORTUNITY:
SUPERGEN IS A SMALL MOLECULE, CANCER DRUG COMPANY IN DUBLIN, CA.
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SEE POSITIONS FROM LIFE TECHNOLOGIES AT WWW.
|TITLE / DESCRIPTION |
|Company |
|Location |
|Date Posted |
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|Senior Manager, Manufacturing |
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|Applied Biosystems Global Operations is looking for a seasoned Senior Manufacturing Manager to lead its Pleasanton, CA... |
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|Life Technologies |
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|Pleasanton, CA USA |
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|08/31/2009 |
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|Intern - Chemical Engineer |
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|We have multiple Chemical Engineering Internships available for Summer 2008. Examples of projects include: - System ... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|Staff Engineer, Informatics |
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|Join the RD Analysis team working on the SOLiD next generation sequencing platform. There are three main areas of resp... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|View full description |
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|Intern - Chemistry Major |
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|We have multiple internships available for students pursuing degrees in chemistry. These positions support various bus... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|Intern - Mechanical/Bio Eng Major |
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|We have multiple Mechanial/Bio Engineering Internships available for Summer 2008. Examples of projects include: - Sy... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|Intern - Biology Major |
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|We have multiple internships available for students pursuing degrees in various aspects of biology. These positions su... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|Intern - Computer Science Major |
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|We have multiple internships available for students pursuing degrees in computer science. Examples of previous projec... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|View full description |
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|Intern - Software Technology |
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|To design software algorithm infrastructure for quantitative reverse transcriptase polymerase chain reaction (RT-PCR) ... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|View full description |
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|Sr. Staff Scientist, Bioinformatics - Next Generation Sequencing |
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|SR STAFF SCIENTIST BIOINFORMATICS RESPONSIBILITIES We are seeking a talented bioinformatician/computational biolo... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|View full description |
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|Technician 2, Service |
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|The Service Technician will perform maintenance, testing, troubleshooting, calibration and repair on a variety of Manu... |
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|Life Technologies |
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|Pleasanton, CA USA |
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|08/31/2009 |
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|Title / Description |Company |Location |Date Posted |
|Associate Product Manager, Genetic Analysis |Life Technologies |Foster City, CA USA|08/31/2009 |
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|PRODUCT MANAGER GENETIC ANALYSIS CONSUMABLES | | |View full description |
|OVERVIEW We are seeking an Associate Product Manager| | | |
|for the Genetic ... | | |Save to MyBeakerBoard |
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|Mass Spec- Field Applications Support- Applied |Life Technologies |Various, NJ USA |08/31/2009 |
|Markets | | | |
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|The Senior Field Applications Specialist is | | | |
|responsible for providing high-level pre-sales and | | |Save to MyBeakerBoard |
|post-sales support for ... | | | |
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|Sr Staff Engineer, Algorithms |Life Technologies |Foster City, CA USA|08/31/2009 |
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|SR STAFF ENGINEER, ALGORITHMS Design, develop, | | |View full description |
|implement and maintain data analysis components, | | | |
|systems and software ... | | |Save to MyBeakerBoard |
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|Staff Engineer, Mechanical |Life Technologies |Foster City, CA USA|08/31/2009 |
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|Major responsibilities include design and | | |View full description |
|implementation of of manufacturing systems for | | | |
|consumable products, and mana... | | |Save to MyBeakerBoard |
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|Product Applications Specialist 3 - PCR Solutions |Life Technologies |Foster City, CA USA|08/31/2009 |
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|SPECIALIST 3, PRODUCT APPLICATIONS RESPONSIBILITIES | | |View full description |
|Drives PCR applications on End-pt PCR and Real-Time | | | |
|PC... | | |Save to MyBeakerBoard |
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|Senior SAP Basis Administrator |Life Technologies |Foster City, CA USA|08/31/2009 |
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|We are currently seeking a Senior level SAP Basis | | |View full description |
|Administrator for our Foster City office in | | | |
|California. In this po... | | |Save to MyBeakerBoard |
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|Chemical Process Technician |Life Technologies |Foster City, CA USA|08/31/2009 |
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|Filling of liquids and powders as well as finished | | |View full description |
|goods in a manner consistant with good laboratory | | | |
|proctices, compli... | | |Save to MyBeakerBoard |
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|Title / Description |Company |Location |Date Posted |
|Senior Scientist Product Development |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|Major Responsibilities: We are | | |View full description |
|currently seeking a skilled and | | | |
|highly-motivated Scientist for a | | |Save to MyBeakerBoard |
|Development and Pilo... | | | |
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|Royalty Administrator |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|The Royalty Administrator position is | | |View full description |
|responsible for supporting the Manager| | | |
|of Licensing Royalty Compliance and | | |Save to MyBeakerBoard |
|the ... | | | |
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|Product Manager Taqman MicroRNA Assays|Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
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|PRODUCT MANAGER TAQMAN MICRORNA | | | |
|BACKGROUND For over 25 years Applied | | |Save to MyBeakerBoard |
|Biosystems has brought leading edge | | | |
|scientifi... | | |Email to a friend |
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|Senior Solution Architect |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|The Senior Solution Architect provides| | |View full description |
|technical and business domain | | | |
|expertise in support of Professional | | |Save to MyBeakerBoard |
|Services. In... | | | |
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|Product Applications Specialist 3 |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|RESPONSIBILITIES The Role of | | |View full description |
|Bioinformatics Applications Specialist| | | |
|is to support the Next Generation | | |Save to MyBeakerBoard |
|Sequencing SOLi... | | | |
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|Application Sales Consultant - Houston|Life Technologies |Various, TX USA |08/31/2009 |
|or Dallas | | | |
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|APPLICATION SALES CONSULTANT | | | |
|DALLAS/HOUSTON OVERVIEW As the leading| | |Save to MyBeakerBoard |
|supplier of life science technology | | | |
|and relate... | | |Email to a friend |
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|Maintenance Technician |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|This position will have a critical | | |View full description |
|role in troubleshooting, diagnosis and| | | |
|repair of consumables manufacturing | | |Save to MyBeakerBoard |
|equipmen... | | | |
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|Product Applications Sr. Specialist - |Life Technologies |Foster City, CA |08/31/2009 |
|Taqman | |USA | |
| | | |View full description |
|PRODUCT APPLICATIONS SPECIALIST TAQMAN| | | |
|PROTEIN EXPRESSION ASSAYS OVERVIEW As | | |Save to MyBeakerBoard |
|the leading supplier of life science | | | |
|... | | |Email to a friend |
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|Staff Engineer, Chemical Process |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|Major Responsibilities: Develops, | | |View full description |
|implements, and qualifies robust, | | | |
|cost-effective processes for | | |Save to MyBeakerBoard |
|manufacturing leadin... | | | |
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|Global Commodities, Procurement |Life Technologies |Foster City, CA |08/31/2009 |
|Specialist | |USA | |
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|The Sr Buyer/Planner will identify | | | |
|sources of supply, negotiate contracts| | |Save to MyBeakerBoard |
|and implement supplier agreements for | | | |
|plasti... | | |Email to a friend |
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|Title / Description |Company |Location |Date Posted |
|Senior Database Administrator-SQL Server |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|Position Location: Rockville, MD SQL Server| | |View full description |
|Database Administrator will work as part of| | | |
|a DBA team that provides 24x7... | | |Save to MyBeakerBoard |
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|Development Scientist |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|Major Responsibilities: We are currently | | |View full description |
|seeking a high-motivated individual to join| | | |
|the Product Development group of... | | |Save to MyBeakerBoard |
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|Inspector 2, Quality Compliance |Life Technologies |Bedford, MA USA |08/31/2009 |
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|Successful performance of job duties | | |View full description |
|contributes to meeting production | | | |
|schedules, customer satisfaction, | | |Save to MyBeakerBoard |
|departmental ... | | | |
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|Senior SAP Configuration Lead |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|Senior SAP Configurator ( Manufacturing and| | |View full description |
|Production Planning) We seek a strong SAP | | | |
|Product Planning and Manufact... | | |Save to MyBeakerBoard |
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|Senior SAP Configuration Lead |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|Senior SAP Configurator ( Finance FI | | |View full description |
|module) We seek a strong SAP Finance Module| | | |
|expert with excellent configurati... | | |Save to MyBeakerBoard |
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|Sr Analyst, Business Process |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|Major Responsibilities: Participate in the | | |View full description |
|identification, evaluation, and | | | |
|implementation of SAP related security | | |Save to MyBeakerBoard |
|too... | | | |
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|Senior Manager - Facility/Maintenance |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|BASIC FUNCTION AND SCOPE OF THE POSITION: | | |View full description |
|Provide technical leadership, mentoring and| | | |
|supervision to the maintenance... | | |Save to MyBeakerBoard |
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|Sr. Analyst, Programmer -SAP BW |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|We are seeking a SAP BW Developer to | | |View full description |
|maintain, monitor and develop the company's| | | |
|SAP BW implementation. This role wil... | | |Save to MyBeakerBoard |
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|Cold Fusion Developer |Life Technologies |Foster City, CA |08/31/2009 |
| | |USA | |
|We have a great career opportunity for an | | |View full description |
|experienced Cold Fusion Developer. You will| | | |
|Collaborate with Business Analy... | | |Save to MyBeakerBoard |
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|Title / Description |Company |Location |Date Posted |
|Field Service Engineer |Life Technologies |Various, CA USA|08/31/2009 |
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|Primary Role The Field Service Engineer is | | |View full description |
|responsible for ensuring a high rate of | | | |
|customer satisfaction through the... | | |Save to MyBeakerBoard |
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|Sr Technical Trainer - DNA Analysis |Life Technologies |Foster City, CA|08/31/2009 |
| | |USA | |
|Major Responsibilities Work within the | | |View full description |
|Technical Training Department to train | | | |
|employees on AB applications. This incl... | | |Save to MyBeakerBoard |
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|Sr Specialist, Technical Training |Life Technologies |Foster City, CA|08/31/2009 |
| | |USA | |
|Major Responsibilities Work within the | | |View full description |
|Technical Training Department to train AB | | | |
|field service engineers and other em... | | |Save to MyBeakerBoard |
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|Product Manager, Sequencing Analysis |Life Technologies |Foster City, CA|08/31/2009 |
|Software | |USA | |
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|RESPONSIBILITIES Responsible for managing | | | |
|the Sequencing Analysis software product | | |Save to MyBeakerBoard |
|family, including developing the... | | | |
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|Sales Rep Genetic Systems - MA/NH/ME |Life Technologies |Foster City, CA|08/31/2009 |
| | |USA | |
|Major Responsibilities - Exceed plan for | | |View full description |
|product responsibility - Provide sales | | | |
|expertise with regard to market, AB a... | | |Save to MyBeakerBoard |
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|Sales Rep Molecular Biology - Boston |Life Technologies |Foster City, CA|08/31/2009 |
| | |USA | |
|Major Responsibilities Exceed plan for | | |View full description |
|product responsibility - Provide sales | | | |
|expertise with regard to market, AB app... | | |Save to MyBeakerBoard |
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|Title / Description |
|Company |
|Location |
|Date Posted |
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|Technical Application Scientist |
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|TECHNICAL APPLICATIONS SPECIALIST RESPONSIBILITIES: The hybrid Technical Applications Scientist (70% field/30% rem... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|View full description |
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|Save to MyBeakerBoard |
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|Call Center Coordinator, 2 |
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|Major Responsibilities Provides phone support activities for the Field Service Support Groups. Requires knowledge... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|View full description |
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|Sales Rep Genetic Analysis AL/MS/FL |
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|RESPONSIBILITIES - Exceed plan for product responsibility - Provide sales expertise with regard to market, AB applica... |
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|Life Technologies |
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|Various, FL USA |
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|Sr InstallSheild and Build Engineer |
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|Major Responsibilities:Seeking a senior InstallSheild and Build Engineer to develop installers for our commercial soft... |
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|Life Technologies |
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|Foster City, CA USA |
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|Product Manager, Public Health |
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|Responsible for products delivered to Public Health customers, including developing long term strategy, defining produ... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|Technical Application Scientist |
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|Key Role Responsibilities and Authorities: The Technical Support Specialist II is responsible for providing a broad r... |
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|Life Technologies |
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|Austin, TX USA |
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|08/31/2009 |
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|Web Administrator |
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|*Note* This is NOT a WEB DEVELOPER position This position is responsible for the deployment and maintenance of g... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|Product Manager PCR |
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|PRODUCT MANAGER CONSUMABLES RESPONSIBILITIES Developing the long-term product direction and managing all customer ... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|Sr. Manager, Global Tech Support, LIMS |
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|Primary Responsibilities - Directs 24/7 global helpdesk operations for SQL*LMS customers worldwide. Coordinates first ... |
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|Life Technologies |
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|Various, CA USA |
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|08/31/2009 |
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|HOME > ABOUT US > PRIVACY > TERMS > CONTACT US > FAQS > [pic]RSS |
|Supplier Quality Engineer |
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|Job Summary: As a key member of the Supplier Quality Organization, you will manage supplier quality issues, supplier a... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|SAP Finance Business Analyst |
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|The role of the Senior Finance Business Systems Analyst involves project management, solution design development as w... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|Facilities Maintenance Mechanic |
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|- Perform preventive maintenance (PM) and repairs on facilities equipment. - Provide support to the Site Services Team... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|Associate Chemical Process Tech |
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|Major Responsibilities: Perform direct labor to produce and/or qualify oligonucleotides which would include synthesis... |
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|Life Technologies |
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|Pleasanton, CA USA |
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|Material Handler 2 |
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|Required Responsibilities: Cycle counting. Literature Fulfillment.Pick and pack products for shipment, and... |
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|Austin, TX USA |
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|Sr Scientist |
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|Applied Markets division of Applied Biosystems produces assays to perform human identification for crime scene investi... |
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|Life Technologies |
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|Foster City, CA USA |
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|08/31/2009 |
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|Sales Specialist SOLiD Next Generation |Life Technologies |Various, CA USA|08/31/2009 |
|Sequenciing- Bay Area | | | |
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|SALES SPECIALIST SOLiD NEXT GENERATION | | | |
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*********************************************************************************
JOBS THAT CROSSED MY DESK THROUGH AUG. 30, 2009
**********************************************************************************************
THIS LOOKS LIKE A VERY EXCITING AND UNIQUE CAREER OPPORTUNITY. THIS WAS PASSED TO ME BY DAN LANGFORD AT THE ROBERT GORDON UNIVERSITY IN THE UK (SCOTLAND). I'D BE GRATEFUL IF YOU MIGHT BE ABLE TO POST THIS ON YOUR WEEKLY JOB LISTING.
I copy the full job description below. Interested candidates should contact Dan Langford at:
Phone: +44 (0)1224 262 159
Mobile: +44 (0)7717 272 325
Email:d.langford@rgu.ac.uk
LinkedIn:
Chief Executive Officer—this is in the UK
Job Summary:
Needed to lead a spin-out company from a world-class University and to build an exciting, proven innovation in molecular in vitro diagnostics into a successful business.
Job Description:
Working with academic team members, the preferred candidate will lead the ongoing development and implementation of the business strategy and bring to the table negotiation, marketing and sales experience and a track record of building successful teams in a spin-out situation.
Our ideal candidate will be self-starting and entrepreneurial and is expected to make a leading contribution to the business planning process through extensive personal networks. It is envisaged that the individual will contribute significantly to licensing, collaboration and fundraising activities enabling the business to develop to the next level.
The ideal individual would have the following competencies:
• Extensive experience gained in human diagnostics and a knowledge of laboratory automation
• Demonstrated knowledge of contract negotiation early stage intellectual property
• Ability to build and manage a small, focussed team
• A Proven track record of closing licensing and investment deals
• Experience in raising equity funding from venture capital providers and/or business angels
• Relevant network of industry contacts with potential customers and development partners
• Experience of the corporate governance and financial management obligations of managing an SME, ideally as executive director of a company
Key tasks:
• Providing strong leadership and direction for the organization including clinical development, commercialization and all operational areas such as Marketing, IT, HR, Legal, Facilities and Finance
• Working with the project team to develop and implement policies and procedures, achieve short- and long-range goals, strategic objectives and plans of the project and spin-out company
• Leading a cohesive management team and other internal and external collaborative groups
• Represent the company at global events through relevant meetings, delivery of formal presentations and other business development activities
• Analyse and balance commercial, financial and technical factors to make sound business decisions
• Build strong, long term relationships with industry partners to achieve performance goals
Job Level:
Senior Management
Register Now to view the company details and apply on line.
*************************************************************************************************
WD_DARSHANA@
DARSHANA NADKARNI LOOKING FOR CATHETER ENGINNER FOR MILPITAS, CA - (EXCITING TECHNOLOGY, SECURE IP) TO WORK ON DEVELOPING PACEMAKER & NEUROSTIMULATION LEADS.
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USES THE INTERNET TO CONDUCT TRADE SHOWS FOR THE PHARMACEUTICAL AND LIFE SCIENCE INDUSTRIES. BESIDES HAVING VIRTUAL EXHIBITS, WE ALSO HAVE A CLICK-BY-STATE JOB BULLETIN FOR BOTH EMPLOYERS/RECRUITERS AND JOB SEEKERS TO USE. THERE IS ONE NEW INTERESTING POSITION WITH THE NIH:
Clinical Medical Officer – $149,000 per year
Please go to our job bulletin job and click on the state of interest or use our Advanced Search Functions to search for jobs. Please read the job descriptions carefully and follow the descriptions to apply.
We are also launching a new service called ePharmaCards – unique eCards with science and pharma themes. Pls be free to check them out.
************************************************************************************************
For more information contact Christy Sterbenz, Project Manager with BeakerSource at csterbenz@ or visit me on LinkedIn-
POSITION: SENIOR MARKETING MANAGER
LOCATION: BAY AREA, CA
Position Summary:
Working with the most dynamic and evolving medical device organization in the country, the Senior Marketing Manager will contribute significantly to the commercial strategy and performance at the company.
In this capacity, the Senior Marketing Manager will develop, lead, and implement marketing plans, key marketing programs, and offer direct support in driving adoption of the company’s surgical system into new and pre-existing procedures across the healthcare industry.
Principal Responsibilities:
The Senior Marketing Manager will:
❑ Work directly with the sales organziation to drive forward marketing initiatives within a defined category of therapy.
❑ Establish and develop call points with surgeons and physicians.
❑ Develop and implement clinical education programs and symposia to drive competency and utilization of the system
❑ Develop and implement live surgical broadcasts via the web to educate and promote the system for target General Surgery procedures
❑ Take ownership of therapeutic/vertical markets in marketing communications for the purpose of downstream marketing exposure to surgeons and physicians for the surgical system.
Key Selection Factors:
1. The candidate will have industry experience from the medical device, medical product or medical equipment industry with products specified or marketed directly to physicians.
2. The candidate will have an undergraduate degree in a related course of study. Advanced degrees, including an MBA, a Masters degree in a life science, or medical training are preferred but not mandatory.
3. The candidate will have specific accomplishments in marketing, preferably beyond pure product marketing and extending to management of a category of therapy or having actively owned market development of a product or therapy.
4. The candidate will have experience in ‘downstream’ marketing, preferably in direct interactions with clinical practitioners, end customers and a large, clinically savvy sales force.
We are looking for bright, achievers with demonstrated energy to take ownership of the product and ensure success for themselves as well as the company.
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MicroCube – the medical device incubator where I work is looking for the following people:
1. Mfg. Process Engineer
2. Regulatory specialist
3. Engineering interns (can be fresh graduates)
Please refer to the page on our website for more details. The interns will be hired as a starting step to a potential full time position
*************************************************************************************************
Steve Burke, Sr. Recruiter
Foxhunt Staffing, Inc.
(650) 941-4237
(650) 941-4260 fax
steve@
Job Title: Product Manager – Global Product Innovation
Department: Marketing
Reports to: Product General Manager
SUMMARY
This position has direct ownership for the design and development of key elements of the product portfolio, and leads customer-driven product development efforts in both product and software. Candidate will be responsible for transforming marketing or business requirements into impactful product features and services, and overseeing and managing the development and delivery into the marketplace. In-market feature performance, post-launch improvements, future product enhancements and new product ideation are also areas of focus for this position.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
• Transform marketing requirements into viable and impactful products and/or product features that meet specific customer needs. Work with cross-functional teams on creating detailed product requirements and use cases, as well as user experience requirements to ensure customer needs are met. Understand cost and timing impacts.
• Create (when necessary) and own business requirements documents that outline key product improvements or changes.
• Work closely with cross functional teams within the organization – including R&D, IT, clinical, and manufacturing to drive product requirements through design, development, testing and launch. Validate that the product going to market is meeting the requirements and is expected to achieve the anticipated impact.
• Develop a deep understanding of our customers (Dentists and Orthodontists) through primary and secondary research, market visits and close sales relationships. Incorporate this understanding into product requirements that are consistent with the long term customer experience vision.
• Validate and improve upon product requirements through user experience reviews, user acceptance testing, and pilot management as appropriate. Work closely with cross functional teams and marketing partners on the commercialization of product launches. Work with Professional Education, clinical, legal/regulatory, customer marketing, customer care, and sales teams to deliver best-in-class product improvement launches.
• For assigned products: monitor on-going health, adoption metrics, and feature usage; collect internal and external feedback; investigate, prioritize, and implement improvements and enhancements to maintain and/or increase benefits of product; work with international counterparts to determine international product development / release plans; determine version or product phase-out plans as appropriate.
EDUCATION and/or EXPERIENCE
• BS or BA required, MBA a plus.
• A minimum of 5-7 years working in product development organizations, with demonstrated successful launches.
• Proven track record of setting product development targets and delivering results a must.
• Experience in medical device or dental product development preferred.
• Self-starter, work in a fast pace environment with the ability to manage and deliver multiple projects.
• Excellent communication and organization skills
• Ability to work well in team (marketing and cross-functional) environment
• Strong project management skills
PHYSICAL DEMANDS & WORK ENVIRONMENT
• There are no specific physical demands required for this position.
• The organization is an exciting, medical devices and e-business company with a highly sought after and proprietary product. The atmosphere is casual and the company is extremely employee oriented with stock-purchase & other competitive compensation plans. There are abundant professional growth opportunities for qualified individuals.
WORK SCHEDULE / HOURS
• Regular business hours
****************************
FYI. If interested, contact Robin Kumar
Robin Kumar
(973) 993-9383 Ext.3477
Robin_Kumar@
Subject: Immediate need of Clinical research Associate - B
My name is Robin and I'm a recruiter at Artech.
Artech has an urgent contract for one of our direct clients:
Job Title: Clinical Research Associate- B
Location: Santa Clara, CA 95054
Duration: 6+ months
Order Number # 10530
Job Description:
Minimum 5 years of CRA experience, preferably in Medical device field.
Ensure timely collection of study documents.
Maintain and control all necessary records.
Oversee upto 25 clinical sites, through follow up phase and protocol amendments.
If you are qualified, available, interested, planning to make a change, or know of a friend who might have the required qualifications and interest, please call me ASAP at (973) 993-9383 Ext.3477, even if we have spoken recently about a different position. If you do respond via e-mail please include a daytime phone number so I can reach you. In considering candidates, time is of the essence, so please respond ASAP.
Artech is a global IT Consulting company with over 30 Fortune 500 customers. You may visit our website at to learn more about us
*************************************************************************************************I
Ruba Khenaisser
Resumes to rkhenais@.
I have 2-6 month opening for a Project Coordinator with a Biotech company in South San Francisco.
We need someone with strong Document Control experience and preferably experience with Documentum and/or Sharepoint. This person should be highly organized to track project status and performance for an integration project. Candidates with any type of project coordinator experience can be considered, so long as it's within a biotech or medical device field (R&D, IT, Manufacturing, etc.)as long as candidate has strong document control and project tracking experience.
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Nancy J. Symonds
President
NJS Recruiting Services
415-491-1541
njs@
I'm writing to ask for your assistance in our efforts to identify candidates for three Manager positions in the areas of Down Stream Purification, Fermentation, and Filling and Finishing. I have attached the job descriptions for your review. There is flexibility to consider candidates at the Associate Director level.
Our client is a growing specialty biopharmaceutical company dedicated to developing the next generation of innovative products in dermatology and aesthetic medicine. They are located in the San Francisco Bay Area.
The company has developed a platform technology which enables topical, needleless, delivery of botulinum toxin and other macromolecules across skin. Our client is in the process of developing a next generation injectable form of BoNT-A that incorporates key elements from the platform technology. The objective of that program is to improve onset and duration of action while eliminating human or animal components in the formulation
Thank you so much for taking the time to review these job descriptions. If someone you know has the skill sets we are looking for, please have them send a CV to njs@ for consideration. If there are any questions, please don't hesitate to call me. I look forward to hearing from your referrals.
NJS Recruiting Services is an executive search firm specializing exclusively in Biotech and Pharmaceutical searches in various areas of drug development. We have been in business since 1994 and are located in the San Francisco Bay Area of California. We work primarily with companies also in the Bay Area. This enables us to develop closer, professional relationships as we visit with our clients regularly at their location.
Job Description
Job Title: Manufacturing Manager, Filling and Finishing
Reports To: Sr. Director, Technical Ops
Job Summary:
The Manufacturing Manager – Filling and Finishing, is responsible for the engineering, start-up, commissioning and qualification of process systems to support the drug product manufacturing process for our toxin manufacturing facility. The manager will build and lead a small team.
Responsibilities:
Implement and run an aseptic cGMP manufacturing process for production of a lyophilized drug product.
Manage the available resources for the start-up, commissioning and qualification of equipment and systems
Develop protocols and participate in the execution of equipment systems testing
Manage system handover from construction contractor to company ownership
Provide trouble-shooting of system operation during start-up and commissioning of manufacturing operations
Proactively communicate between departments and employees
Direct and/or assist in the design and execution of small capital projects
Create and lead a small team
Skills and Experience:
At least 7 years of experience in pharmaceutical/biotech operations, with thorough working knowledge of GMP standards, FDA regulatory guidelines, SOPs and validation principles required
Aseptic processing experience including vial preparation, filling and capping.
Large-scale lyophilization of drug product vials required.
Experience with toxin manufacturing preferred
Strong leadership, organizational planning and project management skills
Strong technical expertise
Excellent communication skills
Ability to work with a cross-functional team
Ability to work effectively with other internal and external organizations
Able to handle multiple projects at one time
Experience with project design, construction, start-up, commissioning and validation as well as leading and supporting factory acceptance tests
Develop technical solutions to complex problems requiring use of ingenuity and creativity
Education:
· Candidates must possess a BS in Mechanical Engineering, Chemical Engineering or related discipline
_____________________________________________________________________________________
Job Description
Job Title: Manufacturing Manager, Downstream Purification
Reports To: Sr. Director, Technical Ops
Job Summary:
The Manufacturing Manager – Downstream Purification, is responsible for the engineering, start-up, commissioning and qualification of process systems to support the purification process for our toxin manufacturing facility. The manager will build and lead a small team.
Responsibilities:
Implement and run a cGMP protein purification process for an API.
Manage the available resources for the start-up, commissioning and qualification of equipment and systems
Develop protocols and participate in the execution of equipment systems testing
Manage system handover from construction contractor to company ownership
Provide trouble-shooting of system operation during start-up and commissioning of manufacturing operations
Proactively communicate between departments and employees
Direct and/or assist in the design and execution of small capital projects
Create and lead a small team
Skills and Experience:
At least 7 years of experience in pharmaceutical/biotech operations, with thorough working knowledge of GMP standards, FDA regulatory guidelines, SOPs and validation principles required
Protein purification processes, including chromatographic separation, centrifugation, and filtration.
Experience with AKTA Pilot chromatographic skids.
Experience with toxin manufacturing preferred
Strong leadership, organizational planning and project management skills
Strong technical expertise
Excellent communication skills
Ability to work with a cross-functional team
Ability to work effectively with other internal and external organizations
Able to handle multiple projects at one time
Experience with project design, construction, start-up, commissioning and validation as well as leading and supporting factory acceptance tests
Develop technical solutions to complex problems requiring use of ingenuity and creativity
Education:
· Candidates must possess a BS in Mechanical Engineering, Chemical Engineering or related discipline
________________________________________________________________________________________---
Job Description
Job Title: Manufacturing Manager, Fermentation
Reports To: Sr. Director, Technical Ops
Job Summary:
The Manufacturing Manager – Fermentation, is responsible for the engineering, start-up, commissioning and qualification of process systems to support the fermentation process for our toxin manufacturing facility. The manager will build and lead a small team.
Responsibilities:
Manage the available resources for the start-up, commissioning and qualification of equipment and systems
Develop protocols and participate in the execution of equipment systems testing
Manage system handover from construction contractor to company ownership
Provide trouble-shooting of system operation during start-up and commissioning of manufacturing operations
Proactively communicate between departments and employees
Direct and/or assist in the design and execution of small capital projects
Create and lead a small team
Skills and Experience:
At least 7 years of experience in pharmaceutical/biotech operations, with thorough working knowledge of GMP standards, FDA regulatory guidelines, SOPs and validation principles required
Large-scale bacterial fermentation experience
Experience with toxin manufacturing preferred
Strong leadership, organizational planning and project management skills
Strong technical expertise
Excellent communication skills
Ability to work with a cross-functional team
Ability to work effectively with other internal and external organizations
Able to handle multiple projects at one time
Experience with project design, construction, start-up, commissioning and validation as well as leading and supporting factory acceptance tests
Develop technical solutions to complex problems requiring use of ingenuity and creativity
Education:
· Candidates must possess a BS in Mechanical Engineering, Chemical Engineering or related discipline
***********************************************************************************************************************
Interested parties should submit resumes at
E-mail resume: fionna.mabeliso@amo.
Business Excellence Leader (BPI)*
Santa Ana OR Milpitas, CA
This Senior Level Process Improvement Manager Role is responsible for the execution and ongoing management of service and operational excellence initiatives in the Global Customer Service Organization. The role leads strategic, complex process improvement projects in conjunction with division goals and imperatives for increasing revenue, optimizing cycle time, reducing defect rates, and improving customer satisfaction. The role requires well developed leadership and project management capabilities with demonstrated success completing core-business, cross-functional, and cross-cultural projects. The role is accountable for delivering strategic results from the application of Six Sigma methodologies and effective change management.
• Leads strategic, complex process improvement projects across GCS and the division.
• Delivers strategic results in conjunction with divisional goals and imperatives.
• Evaluates business processes and determines initiatives that will yield greater productivity and efficiency to enable growth.
• Acts as a cross-cultural change agent to drive and sustain measurable business process improvements internal and external to GCS.
• Act as a mentor, coach, and technical leader in the implementation of Abbott Business Excellence best practices.
Qualifications
• BS/BA required; advanced degree preferred in a business, science, or engineering discipline.
• 10+ years of experience delivering strategic results from BPI initiatives.
• Current Black-Belt certification; Master Black-Belt certification desired.
• Proven expertise in application of Lean and/or Six Sigma to deliver business process improvements.
Other Essential Skills:
• Ability to negotiate and influence key personnel across multiple business units and geographies.
***********************************************************************************************************************
Interested parties should submit resume: fionna.mabeliso@amo.
Apply:
Program Engineer III, Biomedical Optics—Milpitas, CA
Our principal aim is to develop advanced, life-improving vision technologies for people of all ages. This current opening is within the laser vision correction R&D group and requires skill in excimer laser development, optical systems design and with attendant instrumentation. You will be developing commercial medical devices in a design control environment through teamwork with software developers as well as with electrical, mechanical, and quality engineers.
Experience with laser-material interaction processes is essential as we develop new and more effective methods to reshape the human cornea. In our fast-paced, high-tech environment, success is based on creative invention skills, thoughtful project planning, hands-on experimentation, and thorough analysis. The successful candidate will be able to work on two parallel projects, in a mix of team environments, and as an individual contributor.
QUALIFICATIONS
- Portfolio of demonstrated creativity in solving complex UV pulse generation, beam shaping, and beam delivery design challenges in biomedical devices, laser lithography, material processing or similar areas.
- Applied expertise with excimer lasers and optical engineering principles.
- Demonstrated proficiency with programming and optical design software (ZEMAX or Oslo, Code 5, etc.)
- Analytical mind, readily applies product development processes for Change Management, VOC, VOB, DOE, Requirements specifications, Design Control, V&V.
- Hands-on system architect who takes broad thinking to detailed implementation.
- Excellent written and oral communication skills.
- Motivated to shine as part of a development and cross-functional team.
- Driven to lead in a fast-moving high-tech industry.
KEY DUTIES AND RESPONSIBILITIES: % OF TIME OR IMPORTANCE
1. Applying analytical thinking, experimentation, and computer modeling skills to expand AMO’s knowledge of laser/tissue interaction mechanisms to develop methods that reshape the human cornea more effectively and predictably 35
2. Design, specify and validate laser beam generation, beam shaping and beam delivery subsystems for medical UV excimer lasers that optimize performance, reliability and cost-of-goods 35
3. Perform error budget analysis for the LVC process chain as design input into performance improvement projects (treatment alignment, workflow) 20
4. Generate intellectual property and review current patent publications on laser based ophthalmic procedures 10
EDUCATION and/or EXPERIENCE
- Requires a minimum of Master’s Degree and 8+ years of relevant experience. Advanced degree preferred.
- 4+ years demonstrated optical or opto-mechanical design experience.
- Experience with UV lasers & optics required.
- Demonstrated experience with the product development lifecycle.
- Superior written and spoken communication skills plus a track record of cross-functional teamwork.
Abbott is an Equal Opportunity Employer and maintains an Affirmative Action Plan
**********************************************************************************************************************
John Pandes
Senior Staffing Consultant
Gilead Sciences, Inc.
O: (650) 522-5599
Email: John.Pandes@
Senior Medical Writing Specialist
Foster City, CA or Durham, NC
This role can be located in either Durham , NC or Foster City, CA. (Telecommuting is not an option ~ sorry.)
Specific Responsibilities and Skills for Position:
Experience writing CTD submission summaries and overviews, briefing documents, development plans, as well as CSRs and IBs. Knowledge of antiviral and/or cardiovascular TAs a plus.
Essential Duties and Job Functions:
Prepares a wide range of regulatory documents, including clinical study reports, Investigator Brochures and Annual Updates, as well as more complex CTD summaries and regulatory responses, in-line with regulatory requirements and Gilead internal document standards. Contributes to other non-regulatory medical writing activities as required. Participates in submission teams providing advice/guidance for optimal presentation of data for achievement of document objectives. Leads document timeline/resource planning within the submission team. Works collaboratively with functional contributors (clinical, biometrics, virology etc), ensuring all source information / data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines. Medical writing activities are performed independently with little direction from Associate Director / Director level. Leads the compilation of final documents and appendices coordinating clinical, biometrics and regulatory contributions. Leads/contributes to development work in relation to document standards, continuing MS template development and other aspects of document management. Provides submission team contact point regarding requirements for regulatory documents. Participates in both group and moderately complex Company-wide process improvement and development initiatives.
Knowledge, Experience, and Skills:
Specific pharmaceutical: Typically requires a BA degree and minimum 10 years of relevant experience within clinical R&D or regulatory affairs such as pharmaceuticals/biotechnology, which includes 5 years of relevant experience in a medical writing/clinical submissions environment preparing documents for regulatory submissions. General scientific: Typically requires a BA degree and minimum 10 years of relevant experience or a MS degree and minimum of 8 years of relevant experience or a PhD, MD or DVM degree and minimum 4 years of relevant experience. Demonstrated success in the preparation of regulatory documents particularly at the individual study report level. Highly developed and proven medical writing skills. Excellent verbal communication skills. Knowledgeable of regulatory document requirements/guidelines. Understands moderately complex document management, authoring and publishing tools and their applicability for workflow efficiency. Well-developed computer skills including proficiency in Word, Powerpoint and Excel. Use of project management tools and graphics packages also desirable.
If you are interested in being considered for these positions or if you know someone who is qualified, please contact me. I'd appreciate any referrals.
*****************************************************************************
Interested candidates please send resume to:
Vince Graziano
Scientific Medical Writer
Northern NJ Industry: Major Pharmaceutical Company
Salary: $75-$105K
Description:
The Scientific Writer is the medical writing expert responsible for the research, writing and editing of regulatory documents. The incumbent will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission. Responsibilities will include assuring quality and timely preparation of clinical documents across all therapeutic areas, including clinical study reports, clinical study protocols, investigator's brochures, and clinical summaries and overviews.
Qualifications:
Requirements: Bachelor's degree or equivalent, with at least six years experience in scientific discipline and a minimum of four years in Medical Writing. Master's degree, PhD, or equivalent with a minimum of two years previous industry experience. Demonstrated working knowledge of scientific principles. Excellent written and oral communication skills in English. Familiarity with all phases of medical research and ability to learn new medical concepts quickly. Familiarity with statistics and experimental design. Ability to summarize complex data and identify relationships.
Must have Clinical Study Reports and Regulatory submissions experience.
contractrecruiter@
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Medical Writer, Medical Communications (Multiple Positions)
San Francisco Bay Area
Anyone interested or if you know anyone looking, please contact me via
email at shannonp@.
Shannon Peryea
Vice President, Executive Recruiting
Sheila Greco Associates, LLC
174 State Hwy 67
Amsterdam, NY 12010
(518) 843-4611 ext. 252
shannonp@
sheilagreco. com
Celebrating 20 Years of Excellence
Medical Communications Agency:
Medical Director- must have PhD, PharmD, or Md degree and medical communications agency experience
Sr. Account Manager
Account Manager
Speakers Bureau Manager
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Pharma Advertising Agency:
Account Supervisor or Group Account Supervisor
************************************************************************************************* Contact Suzanne George, Sr. Partner
MRI Weston if you meet the reqs.
Suzanne George, Sr. Partner
MRI Weston
Management Recruiters of Weston
Visit our website:
Linkedin:
2645 Executive Park Drive
Weston, FL 33331
954-385-3122
Our client, an established California based Global Medical Device company,
advantageously located in the East Bay Area between San Francisco and San
Jose is seeking the following positions:
Six Sigma Black Belt: Principal Engineer
Principal Engineer will be responsible for the Six-sigma process & design
expertise for mechanical team, with focus on product, process, and test
methods for class III medical devices with technical responsibility for
interpreting, organizing, executing, and coordinating assignments.
Conceiving and assigning plans, conducting research in problem areas of
various scope and complexity that require unconventional or novel
approaches, and require sophisticated research techniques Responsibilities
include:
* Serving as the global technical expert in the application of advanced
theories, concepts, principles, and processes for an assigned area of
responsibility (i.e., subject matter, function, type of facility, or
equipment, or product)
* Keeping current of new methods and developments affecting his/her area,
team or product, recommending changes or new programs
* Evaluating project teams progress and results, recommending changes to
achieve overall objectives. Technically supervise other engineers or
technicians on particular projects, which may or may not be related to
current assigned projects
* Responsible for product design characterization to ensure successful
Design Verification and Validation and developing and validating in-vitro
test methods and for performing design reviews and re-validation assessments
to ensure the safe and environmentally sound start-up of new processes
* Responsible for the purchase or design of equipment that meets health,
safety and environmental standards set by the company
Requirements:
* Education & Experience: BS degree with 14+ years of related
engineering experience; MS with 12+ years of related engineering experience;
Ph.D. with 9+ years of related engineering experience
* Must be a "solid engineer" with a mastery of theoretical and
practical fundamentals and experimental engineering techniques with a
required background in prototypes and design control
* Six Sigma Design or Process Excellence Black Belt certification is
required (Will NOT accept green belt) PE License is a PLUS
* Requires proven ability in Statistical analysis
* 4+ years experience in the medical device industry including
required experience with in vitro product testing
* Other PLUSES: Design valuation experience, vascular access and
Materials Background
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Principal Engineer: Balloon Design
Principal Engineer in Balloon Design will work on complex problems where
analysis of situations or data requires an in-depth evaluation of various
factors. Determines direction and adequacy of designs and test results and
recommends changes. Conceiving and assigning plans, conducting research in
problem areas of various scope and complexity that require unconventional or
novel approaches, and require sophisticated research techniques
Responsibilities include:
* Responsible for extrusion and balloon design in alignment with product
CTQs; Understanding of the relationship between inputs and balloon design
output is essential for success of this position and serve as subject matter
expert on balloon material
* Interactions with environmental and processing conditions
* Strong understanding of IP landscape in order to identify potential
design solutions as well as support Legal department
* Process and / or Design Excellence approach to design,
characterization, and implementation; Develop and implement detailed plans
and systematic processes to proactively manage and address internal and
external product needs; DOE and statistical analysis of data with
responsibility of report writing
* Take-charge, hands-on approach to proactively manage extensive number
of competing design requirements and communicate limitations to the team
* With Sr. Mgmt support, drive accountability and ownership of critical
project milestones
* Coordinate activities with R&D Design Control Systems team and various
Quality teams
* Supports regulatory filings and internal/external audits as needed
Requirements:
* Education & Experience: BS degree with 14+ years of related engineering
experience; MS with 12+ years of related engineering experience; Ph.D. with
9+ years of related engineering experience
* MUST have polymer materials design experience and possess a mastery of
theoretical and practical fundamentals and experimental engineering
techniques
* Experience as team lead is a requirement, not necessarily management of
people but technical lead.
* 4+ years experience in the medical device industry including required
experience with in vitro product testing
* PE License, Six Sigma Design, Black or Green Belt certification a PLUS
* Other PLUSES: Intellectual property experience, Stent
design/development and Design Control
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Principal Engineer: Catheter Design
Principal Engineer in Catheter Design will work on complex problems where
analysis of situations or data requires an in-depth evaluation of various
factors. Determines direction and adequacy of designs and test results and
recommends changes. Conceiving and assigning plans, conducting research in
problem areas of various scope and complexity that require unconventional or
novel approaches, and require sophisticated research techniques
Responsibilities include:
* Serving as the global technical expert in the application of advanced
theories, concepts, principles, and processes for an assigned area of
responsibility (i.e., subject matter, function, type of facility, or
equipment, or product)
* Keeping current of new methods and developments affecting his/her area,
team or product, recommending changes or new programs
* Evaluating project teams progress and results, recommending changes to
achieve overall objectives. Technically supervise other engineers or
technicians on particular projects, which may or may not be related to
current assigned projects
* Responsible for product design characterization to ensure successful
Design Verification and Validation and developing and validating in-vitro
test methods and for performing design reviews and re-validation assessments
to ensure the safe and environmentally sound start-up of new processes
* Responsible for the purchase or design of equipment that meets health,
safety and environmental standards set by the company
Requirements:
* Education & Experience: BS degree with 14+ years of related engineering
experience; MS with 12+ years of related engineering experience; Ph.D. with
9+ years of related engineering experience
* Must have Catheter Design, IV product development and VOC experience
and possess a mastery of theoretical and practical fundamentals and
experimental engineering techniques
* Experience as team lead is a requirement, not necessarily management of
people but technical lead.
* 4+ years experience in the medical device industry including required
experience with in vitro product testing
* PE License, Six Sigma Design, Black or Green Belt certification a PLUS
* Other PLUSES: Intellectual property experience, Stent
design/development and Design Control
NOTE: RELOCATION ASSISTANCE IS AVAILABLE FOR ALL THREEPROSITIONS.
********************************************************************
Jobs That Crossed My Desk Through August 23, 2009
******************************************************************************************
Please send resume to Darshana Nadkarni at wd_darshana@.
There is an immediate job opening for a Catheter Engineer. Requirements include Bachelors in Engineering plus minimum 5 years experience working in teams developing catheter systems, from conception through production with minimal supervision. Ideal candidate will have demonstrated ability to contribute in all phases of new catheter product development including ideation, concept development, detailed engineering, and design for manufacturing. This is an exciting opportunity in early stage company with promising technology, solid funding, and secure IP. Responsibilities include, ability to work with other members of the product development team to conceive, develop, prototype, test and debug novel catheter systems in accordance with established policies, goals, and objectives.
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For those interested in medical devices, check out Acclarant; it is doing lots of hiring:
California Openings
Cost Accountant
Customer Service Manager
Director, Marketing
Director, Quality Assurance
IT Specialist
Marketing Product Manager
Principal Process & Product Development Engineer
Receptionist / Administrative Assistant - We have two part-time positions available
Regulatory Project Manager
Senior Document Control Specialist
Senior Machinist
Senior Manufacturing Engineer
Senior Marketing Manager
Senior Process & Product Development Engineer
Senior R&D Engineer
Senior R&D Engineer
Senior R&D Technician
Senior Sales Operations Analyst
Quality Engineer Consultant
**********************************************************************************************
Janet Jarboe
Jarboe and Associates
JanetJarboe@
(OFFICE) 970-686-5899
(MOBILE) 970-689-2962SERVING PROFESSIONALS SINCE 1997
For twelve years Jarboe and Associates has specialized in placements for small, mid-size, large and pre-IPO companies.
Our staff identifies opportunities and candidates in Pharmaceutical Technologies, Pharmaceutics and Drug Delivery, Analysis and Pharmaceutical Quality, Regulatory Science, PPDM, Process Analytical Technology, Drug Design and Discovery, Clinical Sciences and Writing.
Our goal is to effectively communicate and conduct efficient and confidential searches.
Position Descriptions are attached below.
Jarboe and Associates runs a very confidential business and we look forward to your feedback and being of assistance to you, your company or colleagues.
Analyst/Sr. Analyst, Process Development - California
This position will be responsible for performing and designing protein analyses in support of the monoclonal antibody development projects at company. Essential functions include, but are not limited to the following:
• Perform analytical testing of intermediates and final products following SOPs.
• Perform a wide range tests such as: HPLC, SDS Page, ELISA, pH, appearance, UV, IEF, A280, etc.
• Maintain detailed records of assay performance; analyze and interpret test results.
• Recognize results that deviate from established standards, and recommend appropriate actions. Perform testing necessary to investigate out-of-specification test results.
• Recommend revisions to procedures to improve efficiency and ensure compliance with regulatory requirements and internal procedures.
• Establish SOPs for new assays, materials, products and equipment.
• Effectively and efficiently train other analysts in the performance of complex test methods.
• Comply with good housekeeping and company safety practices.
Position Requirements:
•Position requires science degree in Biochemistry or related discipline with 3-5 years experience in the Biotechnology industry.
•Candidates should possess strong protein analytical skills, expensive hands-on experience with HPLC and ELISA, SDS Page is required, and proficiency with CE and MS is desired.
•Should have knowledge of GMP, FDA, and USP regulations and a basic understanding of statistics.
•Strong organizational, communication and interpersonal skills required, with an ability to flexibly work in a fast-paced multi-tasking environment.
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Director/Senior Director, Molecular Discovery - California
• The successful candidate will support Executive Vice President and Head of R&D in the management of all aspects of molecular biology related to target discovery and validation and development of novel cancer therapeutic monoclonal antibodies (MAbs), including gene discovery and analysis, molecular profiling, bioinformatics and modeling systems, antibody engineering, gene expression modulation, target and antibody product-related expression systems, gene characterization of unique cancer cell populations, and other molecular applications to support pr-clinical and clinical activities.
• The candidate will also participate in activities related to molecular characterization of biomarkers associated with company’s MAb products. Responsibilities include the identification and implementation of novel technologies for facilitation of such activities.
• The candidate will supervise groups with relevant activities and will work closely with other Research and Development Directors and their teams in a cross-functional environment to advance research and pre-clinical programs.
• The candidate will work closely with teams to facilitate collaborations related to research and pre-clinical activities.
Position Requirements
X Advanced degree (Ph.D., or equivalent) with at least 10 years experience in an industry setting, molecular biology, molecular genomics, bioinformatics and related areas. with demonstrated track record of
X Proven record in design and implementation of activities related to gene discovery and characterization, gene profiling, bioinformatics,
X Demonstrated record in driving scientific and technical innovations, as evidenced by first or senior authored publications in top-tiered journals
X Demonstrated successful program leadership and multi-project coordination
X At least 5 years of management experience of multiple groups
X Proven track record in leading programs to achieve goals and timelines
X Ability to perform successfully in a cross-functional team environment
X Excellent written and verbal communication skills
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Target Discovery – California
We are seeking a highly motivated scientist with strong background in molecular biology or related field with microarray chip, bioinformatics and cancer biology experience in a biopharmaceutical organization. The position involves target discovery and biomarker identification for therapeutic antibody development, including experimental design, data mining, target review, expression profile validation and target candidate selection. The successful candidate is expected to work creatively, independently and collaboratively in a dynamic team environment.
Responsibilities include microarray chip experimental design, specimen processing, data mining, gene characterization at the genomic level, and expression profiling by qPCR. The position requires application of various molecular biology techniques, cell signaling, protein biochemistry and data analysis skills to design, execute and interpret experiments. In addition, the candidate will be involved in interfacing with scientists within cancer research and antibody development areas, writing reports and timely communicating results to other members of multidisciplinary teams.
The successful candidate will have a PhD in molecular biology, biotechnology, biochemistry or related discipline with minimum 5 years of relevant industry experience. Other required experience includes expertise in a broad range of molecular and cellular techniques surrounding aspects of microarray-based discovery, biomarker identification and target selection for product development. Experience with management of research associates and demonstrated leadership is preferred. Excellent verbal and communication skills, as well as the ability to work in a dynamic team environment are essential.
The successful candidate will have a PhD in molecular biology, biotechnology, biochemistry or related discipline with minimum 5 years of relevant industry experience. Other required experience includes expertise in a broad range of molecular and cellular techniques surrounding aspects of microarray-based discovery, biomarker identification and target selection for product development. Experience with management of research associates and demonstrated leadership is preferred. Excellent verbal and communication skills, as well as the ability to work in a dynamic team environment are essential.
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Associate Scientist/Scientist, Tissue Analysis Group - California
The successful candidate will employ immunohistochemical and microscopy techniques to screen and identify novel antibodies for use in immunohistochemistry, determine target antigen expression in both animal and human tissues, perform tissue cross-reactivity studies and analyze the biomarker expression and pathology of tissues received from in vivo antibody efficacy studies.
The incumbent will be required to independently design and conduct experiments including interpretation of results, analysis of data and preparation and presentation of reports.
As an Associate Scientist/Scientist there is significant opportunity for scientific collaboration and leadership. The individual will participate in project teams to provide presentation and interpretation of immunohistochemical results as well as becoming a prospective project leader in the validation of a therapeutic antibody target. The ability to work as part of a multi-disciplinary team to design, implement and execute experiments is vital.
Position Requirements:
o A PhD in Cancer Biology, Pathology or a related field
o Proven record of research capabilities, as evidenced by publications and/or patents
o Skilled in microscopy and sample interpretation
o Experienced in digital image acquisition and image analysis
o Proficient in performing immunohistochemistry on paraffin and frozen tissue sections
o Experienced in fixation, processing and embedding of tissues as well as frozen and paraffin embedded section preparation
o Self-motivated and demonstrable leadership capability
o Excellent organizational skills to balance work load between several projects in a fast paced environment in order to accomplish assigned objectives
o Strong interpersonal and communication skills and the ability to work in a team environment
• Knowledge and experience in biopharmaceutics, toxicology, toxicokinetics, ADME and pharmacokinetics with therapeutic antibodies and antibody drug conjugates
• Knowledge of FDA regulations pertaining to non-clinical and clinical drug development.
• Well developed oral and written communication
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Director, Regulatory Affairs – California – reports to Vice President Operations
Responsible for development and execution of global regulatory strategies and regulatory agency interactions. Regulatory role spans pre-IND and early clinical development of antibody products for proprietary cancer targets in multiple solid tumors. Position is a key member of product development team and interfaces regularly with research, manufacturing, quality and clinical organizations within company global operations. Position is “hands-on” and also includes coordinating the preparation and submission of all regulatory documents and reports to FDA and equivalent international organizations.
Requirements:
-Bachelor’s degree in life sciences, Chemistry, Biology preferred. Advanced degree is a plus.
-8-10 years previous biotechnology and/or pharmaceutical drug development experience.
-Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development.
-Recognized as an expert in regulatory strategy and submissions.
-A minimum of 5 years regulatory affairs experience preferably involving direct contact with the FDA; full knowledge of FDA & ICH regulations and guidelines, and the ability to provide interpretations of that information to others.
-Proven record of successful IND/NDA submission and negotiations with the FDA. Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to others in the department as needed.
-Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members. Excellent written and oral communication skills, with writing ability to meet regulatory requirements and standards.
-Ability to communicate effectively and maintain effective working relationships. Must be able to positively influence and direct staff and colleagues and groups within company global organization. Highest integrity with respect to professional standards and maintenance of proprietary, confidential information.
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Associate Director/Director, Toxicology Lead– reports to Vice President, Development – California
Directs and manages company’s toxicology programs for therapeutic MAbs. Prepares non-clinical development plans including necessary studies and their timing. Designs and reviews preparation of protocols for non-clinical toxicology/toxicokinetic studies. Performs site visits and makes site selection decisions. Serves as Toxicologist on Program Development Teams. Reviews, provides comments and approves study reports for toxicology and toxicokinetic non-clinical studies. Prepares and reviews non-clinical toxicology sections in documents (IND, IDB, BD, NDA) and responses to regulatory agencies.
Position Requirements • Ph.D in toxicology, biochemistry, pharmacology, pharmacokinetics or related sciences; minimum of 10 years of pharmaceutical industry, including 7 years in toxicology and management experience
• Comprehensive knowledge of drug development (non-clinical and clinical)
• Experience with non-clinical CROs
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Formulation Development Scientist
The successful candidate will play a key role in developing and implementing formulations for the development products of company’s anti-cancer monoclonal antibody. The scientist will interact with the functional groups in the Development, QA/QC, and CMC teams to define and oversee strategy for formulation development. Essential responsibilities include but are not limited to:
• Lead the design and execution of experimental programs to develop phase I and II clinical formulations
• Supervise pre-formulation activities, such as (pH-dependent) solubility, stability, and excipient compatibility testing of new products
• Develop formulations of adequate stability for research, pharmacology, toxicology and early clinical studies
• Characterize prototype formulations and support development of corresponding analytical methods
• Develop and scale-up of formulation processes using DOE.
• Maintain a current awareness of formulation and delivery technologies.
• Maintain a current awareness of and enforce applicable government regulatory, safety, occupational health, and environmental requirements.
• Work closely with other Research and Development teams, actively supporting testing of new drug formulations at various stages of development, meeting project timelines and goals
• Contribute to CMC sections for regulatory filings.
Position Requirements: • Ph.D. in a scientific discipline (Biochemistry, Chemical Engineering, or Biochemical Engineering) with 5+ years of relevant experience in the pharmaceutical /biotechnology industries.
• Experience in the pharmaceutical industry is preferred in formulation development or related biochemistry related areas of development (e.g. purification, stability, analytical).
• Experience working with monoclonal antibodies and exposure to early phase formulation development activities
• Experience with IV formulations as well as formulation development for poorly soluble compounds would be desirable.
• Proven experience managing the scale-up and manufacturing of parenteral dosage forms
• Proven ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to pre-formulation and formulation development, using a rational, scientific approach.
• Supervisory experience preferred.
• Must be highly motivated, have excellent organizational and communication skills, and must be able to work independently and as part of a multi-disciplinary team.
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Purification Development Scientist
The successful candidate will play a key role in developing, characterizing, validating, and implementing monoclonal antibody purification processes from laboratory to pilot scale. The scientist will apply engineering and biological expertise to collaboratively develop and optimize purification processes suitable for cGMP manufacturing, and will interact with the teams within Process Development as well as collaborate with members from Manufacturing, Quality Control, Quality Assurance, and the Biotechnology Labs of company in Japan. The scientist will also be responsible for new technology development and process optimization as it benefits company current and future purification platforms. Essential responsibilities include but are not limited to:
• Design, develop, and implement recombinant protein purification and recovery processes from laboratory to pilot scale using mammalian cells
• Serve as a technical expert in protein purification within the organization and provide support to the equipment and documentation requirements of GMP manufacturing suites and development laboratory
• Work with Manufacturing and assist for technology transfer to cGMP manufacturing, provide technical support/ and support troubleshooting of existing processes.
• Work both independently and in collaboration with the Purification Process Development team and ensure that corporate objectives are met.
• Write and review documentation to support regulatory filings
• Generate, analyze, and report results of experiments and present at meetings within company.
Position Requirements • Ph.D. in a scientific discipline (Biochemistry, Chemical Engineering, or Biochemical Engineering) with 5+ years of relevant experience in the pharmaceutical /biotechnology industries.
• Knowledge of the design, optimization and scale-up of purification processes is a necessity. Direct experience with purification process development and process transfer for clinical or commercial manufacturing of biopharmaceutical product(s) highly preferred.
• Hands-on experience with protein purification unit operations such as centrifugation, clarification, precipitation, chromatography and ultrafiltration.
• Knowledge of protein biochemistry and competence in routine protein analytical characterization tools such as HPLC, electrophoresis, and spectrophotometry is also required.
• Process validation and cGMP experience is desirable.
• Supervisory experience preferred.
• Must be highly motivated, have excellent organizational and communication skills, and must be able to work independently and as part of a multi-disciplinary team.
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Project Manager - Southeast
-experience in mergers and acquisition.
-MUST be fluent in Japanese.
-5-7 years experience
-MBA preferred, but not required.
-Project Management experience required
Manager Medical Publications
Responsible for the development of scientifically and medically accurate publications for company’s marketed products. Interacts with other functions; Regulatory, Medical, DDPM, Legal, Marketing and other departments. Serves as primary liaison with internal and external opinion leaders, investigators, authors, and affiliates on publication activities related to the therapeutic area. The goal is to ensure the appropriate integrated communication of scientific communications, a process of quality, speed, and consistency to provide maximum effect of critical scientific information.
• Develop integrated publication strategies detailing the appropriate scientific communication for marketed products within the therapeutic area
• Coordinate the publication plans to identify potential for collaboration and resource sharing; impact messaging across compounds; and to maximize data effect at selected venues for therapeutic area
• Analyze published data and determine strategies to enhance literature base on company products
• Interact directly with Clinical, Statistics, Regulatory Affairs, Marketing, and Medical to understand communication objectives for the therapeutic area and develop appropriate scientific communications
• Review current educational message platform, plan and processes; identify areas for improvement to increase quality, process and cost efficiency; facilitate actions for improvement
• Shared responsibility to define and maintain database “best practices”
• Review manuscripts, abstracts, and poster content as appropriate
• Attend review meetings conferences, symposia and other meetings as necessary or as assigned and act as liaison between Strategic Publications and external content contributors
• Manage Strategic Publications budget for therapeutic area
• Determine need for, timing of, and content of publication advisory boards
• Manage publications vendor
• Maintain current knowledge on publishing industry standards and best practices and apply them to business
Position Requirements: Health Care Professional preferred, with at least 3-5 years in clinical practice, and/or 3-5 years of pharmaceutical industry experience required.
• 3-5 years of publications and editing experience
• Significant project management experience
• Effectively work with and lead cross functional teams
• Excellent written and oral communication skills
• Working knowledge of pharmaceutical clinical development and product life-cycle management
• Significant experience and knowledge of clinical trial reports, data presentation, and interpretation.
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Associate Director, Clinical Data Management - Colorado
Requirements:
• BA/BS with 10 years data management experience in a biotechnology/pharmaceutical setting or MS/MA with 5 years data management experience
• 5 years experience managing a staff of 5+ employees
• Experience with clinical data management, clinical study database design and implementation, and generation of clinical study reports
• Experience with electronic data capture system (EDC); experience with Medidata RAVE and ARISg desirable
• Knowledge of commercial coding tools and clinical databases and programming, and experience utilizing them to code medical terms and medications
• Works effectively as a member of multiple teams and has the ability to lead these teams
• Strong interpersonal and communication skills, both oral and written
• Strong knowledge of the clinical drug development process
• Familiarity with regulatory submissions
Summary:
Reporting to the VP Biostatistics and Data Management, this position is responsible for directing and supervising all activities associated with the data management department, processes through clinical trials, and overall quality and integrity of the clinical data. This position will manage a group of six Clinical Data professionals.
Responsibilities:
• Leads and directs the Clinical Data Management department, sets the tone of the department through example, and coordinates activities of the department in order to meet project deliverables
• Keeps abreast of industry trends to efficiently capture data from clinical trials using electronic data capture systems (EDC), clean the data, and lock databases in a timely manner
• Writes and updates Standard Operating Procedures (SOPs) and Work Instructions (WIs), as needed
• Provides data management input for all clinical trial synopses and protocols prior to the design and implementation of EDC databases
• Ensures electronic case report forms (eCRFs), eCRF completion instructions, and data validation specifications are completed prior to implementation of EDC databases
• Executes study-specific procedures compliant with regulatory and internal requirements and supervises and mentors others to do so
• Represents Clinical Data Management in project team meetings
• Supports the generation of clinical study reports
• Oversees the supervision of CRO data management activities, which includes evaluating and selecting CRO vendors and working with project leaders and clinical team members
• Assumes responsibility of special projects, programs and studies as needed
• Works with other departments within Clinical Development to optimize study conduct by facilitating communication, defining roles, building efficiencies and mentoring direct reports to do so
Management:
• Supervises, mentors, and trains Clinical Data Management team members
• Sets the tone of the department through example
• Coordinates activities of the department in order to meet project deliverables and timelines
• Identifies and reports study conduct trends to the head of Biostatistics and Data Management
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Clinical Manager - title to be determined - also requires GLP QA experience – New Jersey
description available soon, please let me know if interested
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Manager / Associate Director of Analytical Development – NJ – established outsourcing model transitioning to full pharma
Main Duties & Responsibilities:
-Identify, select, and manage CROs providing analytical chemistry services.
-Lead the development of analytical procedures in support of pharmaceutical drug substance and product development projects.
-Responsible for process improvement activities.
-Able to zero in and identify areas of opportunity for improvement of analytical methods.
-Ensure that analyses of experimental and stability samples are conducted strictly in accordance with cGMPs, company's SOPs and protocols.
-Ensure that all laboratory documentation is completed to the highest quality standards and that any formal investigations e.g. Out of -Specification (OOS), Changes or Deviations in Data, are conducted promptly and thoroughly
-Convey results of analytical studies and participate in project discussions within development teams.
-Keep up to date with technical advances in analytical and pharmaceutical sciences.
-Stay abreast of current trends in regulatory requirements in the field of CMC.
-Responsible for preparation and/or review of the analytical chemistry portion of the CMC section of a drug product submission.
-Pre-formulation studies in order to provide data on APIs that will lead to development of suitable pharmaceutical products
-Review and approve all analytical method development protocols and reports.
-Review and approve all release and stability specifications.
-Manage the activities of one chemist in to ensure that studies are completed in accordance with project timelines and expectations.
Requirements:
-Ph.D., M.Sc. or B.S. in a science related to Pharmaceutical Analysis
-Ph.D. with 6 years or M.Sc. with 10 years or B.S. with 12-15 years of pharmaceutical analytical development experience in the pharmaceutical industry
-Good understanding of analytical method validation requirements of pharmaceutical industry
-Good understanding of the chemistry of pharmaceutical APIs and of analytical techniques for their characterization
-Candidates must have a good theoretical knowledge of chromatographic sciences and spectroscopic technologies e.g. UV, IR, MS, NMR, XRD
-Very positive interests in keeping up to date with new technologies and developments in analytical sciences
-Good understanding of cGMP, ICH and FDA requirements
-Comfortable working in a “virtual” environment
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Building world class Clinical Pharmacology group for stable, successful, large company.
Seeking candidates for positions to be filled in 2010.
1) Clinical Pharmacology seeking candidates with Pop PK experience. (3 positions)
2) Experimental Medicine seeking candidates, M.D. and/or PhD, can consider those with all academia experience/ industry experience welcome (3 positions)
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Research Leader, Toxicologist- New Jersey established outsourcing model transitioning to full pharma
Description:
Research Leader for toxicology section responsible for all aspects of toxicology from early discovery through clinical development support.
The successful candidate should have strong interest and experience in toxicological sciences to undertake and lead the discovery and regulatory toxicology studies. The toxicologist participates fully on Project teams and subteams, and has frequent interorganizational and outside collaborative contacts.
Regulatory work includes the planning, conduct, reporting and review of toxicology studies, including peer-reviews.
Additional responsibilities include:
Review study protocols and make recommendations regarding the design of the non-clinical toxicology and anatomic pathology portions of toxicology studies.
Conduct gross examinations of animal tissues from toxicology and investigative studies and interpret and explore the significance of results.
Qualification:
PhD and/or DVM in Toxicology with DABT
Over 10 years experience in toxicology pharmaceutical development
Knowledge and experience in FDA regulations pertaining to non-clinical and clinical drug development
Strong scientific background and the ability to critically assess scientific toxicology data
Extensive experience in animal necropsy Experience in pathological evaluation would be a plus
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Research Leader, Veterinary Pathologist – New Jersey –established outsourcing model transitioning to full pharma
Research Leader for pathology section and is responsible for all aspects of pathology from early discovery support through clinical development.
The successful candidate will have the opportunity to evaluate and interpret outcomes from both discovery and regulatory toxicology studies. The pathologists participate fully on Project teams and subteams, and have frequent interorganizational and outside collaborative contacts.
Regulatory work includes the planning, conduct, reporting and review of toxicology studies, including peer-reviews.
Additional responsibilities include:
-Support drug discovery and development by providing pathology support in the design and conduct of toxicology experiments which focus on characterizing the safety of novel therapeutic targets and discovering and developing new chemical entities intended to modulate those targets. ---Review study protocols and make recommendations regarding the design of the clinical pathology and anatomic pathology portions of toxicology studies.
-Conduct gross and microscopic examinations of animal tissues from toxicology and investigative studies and interpret and explore the significance
of results of clinical pathology, organ weight, necropsy, and histopathology data.
-Create or contribute to pathology reports that accurately and completely reflect the data collected and the significance of the data to drug registration and human safety.
-Provide investigative pathology leadership for drug discovery teams.
Qualification: This position requires a DVM preferably with PhD in Pathology or a related field and Board-certified/eligible by the American College of Veterinary Pathologists. Familiarity with Good Laboratory Practice (GLP) guidelines and 3-5 years experience working in pharmaceutical industry. Proven ability to communicate clearly and effectively and to foster productive dialog on complex topics is required as well as the ability to contribute effectively to sound decision making in a manner that is timely and consensus based. The ability to introduce new ideas, practices and technologies
to effectively enhance the drug development process is expected.
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Numerous positions for Medical Doctors with Industry experience (Illinois & California) including those listed below
-Medical Director to Executive Director/VP –GERD
-Medical Affairs Director, Latin America
-Medical Director, Medical Science - Oncology
-Senior Medical Director, Medical Science – CNS
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Sr. Manager/Assistant Director, CMC – Illinois
Responsible for planning and/or coordination of CMC and related activities for multiple projects with minimal guidance from departmental senior management (Senior Director or Vice President). Leads or coordinates the conduct and timely completion of CMC tasks for assigned projects, including internal input regarding internal project strategy and strategic plans with development collaboration partners. Leads or coordinates the identification, selection, and supervision of contract organizations including contract formulation, manufacturing and/or analytical method development labs as for both drug substances and drug products. Prepares budgets and other strategic forecasts for assigned projects.
1. Plans and/or coordinates execution of the drug substance and drug product development activities between PTM (Pharmaceutical Technology Management) and external development or contract organizations for assigned projects, with minimal guidance from supervision, to assure timely development, registration and commercialization of investigational drug products.
2. Represents PTM on global and local project teams to input on CMC scientific strategy and tactics. This includes strategic and tactical leadership of project teams which involve external development collaboration partners.
3. From a technical and business standpoint, leads or coordinates the identification, evaluation and selection of appropriate organizations for development and commercial manufacturing activities. Coordinates these activities with those of other departments (QA, Legal, Supply Chain, Procurement) as needed to assure that selection and implementation is efficient and effective. Provides substantial input and leadership, as needed, regarding the preparation and negotiation of development and supply agreements.
4. Leads or makes substantial scientific contributions to strategic CMC project teams for assigned projects. Identifies technical or resource issues, and takes independent remedial action if needed to prevent delays in timelines. Works with management to negotiate appropriate project deliverables with project teams, and interacts with other project team members to resolve questions or issues as required assuring that project deliverables are on time.
Position Requirements: • A M.S. or Ph.D. in Pharmacy, Pharmaceutics, life sciences or Chemistry plus 3-5 years of experience in the pharmaceutical development of investigational drug candidates is required. A B.S. in Pharmacy or Chemistry with additional relevant experience (5-10 years) can be considered. Title and grade will be based degree and experience as well as the degree of fitness to the Essential Job Responsibilities
• Experience with multiple aspects of the process development, analytical characterization, process scale-up and/or regulatory registration of biotechnology drug substances proteins or peptides) is required.
• A thorough knowledge of current pharmaceutical and related industry and processes and practices, and the ability to leverage this knowledge to optimize group and departmental processes is essential.
• Experience in the management of contract research organizations or collaboration partners is preferred.
• Excellent communication and project management skills are required as this position is responsible for the scientific evaluation and coordination of work performed by external organizations.
• The ability to manage multiple projects and to work well within a team environment are also essential.
• An working understanding of GMP requirements and FDA/ICH guidance is required, as well as facility with commonly available computer tools for project management and data evaluation.
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Manager, Clinical Pharmacology
Responsible for providing clinical pharmacokinetic (PK) and pharmacodynamic (PD) expertise to LWT and GWT for multiple drug development programs with minimal management supervision. Responsible for clinical PK/PD study design, protocol preparation, implementation, data analysis
and study report preparation. Responsible for managing the activities of personnel associated with conduct of Clinical PK/PD studies and assurance
of compliance with SOPs, and FDA and ICH regulations. Responsible for preparation of PK/PD components of Briefing Documents, INDs and NDAs.
PK/PD Expertise. Provides PK/PD input to the strategic development plans for multiple drug development programs with minimal supervision from department management.
2. Planning/Protocols. Designs and prepares protocols for clinical PK/PD studies with minimal direction.
3. Site Selection. Provides input in making site selection decisions; assesses overall site quality on an ongoing basis; helps resolve site problems; supports CRAs and Sr. CRAs on site-related issues.
4. Planning/Budget. Evaluates clinical study resources and proposes changes as necessary. Prepares CRO and site budget proposals. Monitors expenditures and payments.
5. Data Analysis. Performs clinical PK and PD data analysis using a variety of software programs and using external resources as necessary.
6. Project Management. Manages projects to ensure completion to meet established objectives in accordance with SOPs and FDA/ICH requirements. Coordinates internal resources (e.g., drug supply, data management, biostatistics); forecasts and manages drug and drug supply needs for development programs. Provides interim reports to Biopharmaceutical Sciences management and project teams regarding subject enrollment and overall study conduct.
7. Study Reports. Prepares and reviews study reports for completed PK and PD studies. Prepares and reviews PK and PD components of study reports for completed Phase II/III studies.
8. Regulatory Documents. Prepares the PK/PD components of Briefing Documents, INDs and NDAs with minimal supervision from department management.
9. Presentations/Publications. Participates in project reviews and presents study status and results to
APUS management. Attends professional meeting and presents study results as appropriate. Publishes study results as appropriate.
10. SOPs and Regulations. Understands APUS SOPs, regulations/guidelines governing drug development (FDA, ICH, cGCP) and ensures that they are followed.
11. Training. Participates in on-going training and in the training of Sr. CRAs, CRAs and Clinical Research Specialists.
12. Other. Duties as assigned by supervisor.
Position Requirements: PhD, Pharm.D, MS, BS in Pharmacy or life sciences with extensive training in pharmacokinetics and pharmacodynamics and data analysis. Five years of Phase I clinical trial experience or equivalent. Knowledge of Clinical Research Organization industry for clinical trials. Knowledge of drug development process and ability to design and implement Clinical Pharmacology development plans. Proven project and time management skills
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Pharmacokineticist, Clinical Pharmacology
Responsible for providing clinical pharmacokinetic (PK) and pharmacodynamic (PD) information needed to make a sophisticated design of clinical pharmacology studies based on advanced PK/PD modeling & simulation including population pharmacokinetic approaches (Pop PK) to project teams for multiple drug development programs from a variety of therapeutic areas. Assist in preparation of the Clinical Pharmacology development plan. Support clinical study managers across projects. Responsible for the preparation of PK analysis plan, data analysis and preparation of PK/PD components of study reports. Assist in preparation of Briefing Documents, INDs and NDAs and representing Clinical Pharmacology to regulatory agencies. Responsible for assurance of compliance with SOPs, and FDA and ICH guidelines and regulations.
PK/PD Expertise. Provides PK/PD and Pop PK input to the strategic development plans for multiple drug development programs in a variety of therapeutic areas. Recognized as an expert in PK/PD and Pop PK both inside and outside the company.
2. Organization. Anticipates and plans for human resources needs; organizes staff, sets goals, timelines and priorities to meet program objectives and establishes appropriate course of action for assigned programs. Provides direction, leadership and learning opportunities to enhance the development of subordinates, if any.
3. Planning. Develops and takes the initiative in preparing the Clinical Pharmacology development plan from PK/PD point of view, including necessary studies and their timing, for integration into the Global Drug Development plan. Interacts and collaborates closely with Clinical Pharmacology of API and for the integration of development strategies
4. PK analysis plan. Designs and prepares analysis plan for clinical PK/PD studies. Designs and prepares population PK/PD component of Phase II/III studies as needed.
5. Site Evaluation. Provides input in making a decision about external resource selection; assesses overall site quality on an ongoing basis; helps resolve site problems; supports Clinical Study Manager on site-related issues.
6. Data Analysis. Performs clinical PK/PD data analysis using a variety of software programs, i.e. WinNonlin, NONMEM and SAS and using external resources as necessary.
7. Program Management. Manage and coordinates internal and external resources (e.g., PK/PD analysis, biostatistics) to provide timely response needed for development programs in accordance with APUS SOPs and FDA/ICH requirements. Provides interim reports to Biopharmaceutical Sciences management and project teams.
8. Study Reports. Prepares and reviews PK/PD components of study reports for completed PK and PD studies and Phase II/III studies.
9. Regulatory Agency Interaction. Support the preparation of the PK/PD components of Briefing Documents, INDs and NDAs with minimal supervision from department management. Represents Clinical Pharmacology in meetings with FDA and other agencies as needed.
10. Presentations/Publications. Participates in project reviews and presents study status and results to management. Attends professional meetings and presents study results as appropriate. Publishes study results as appropriate.
11. SOPs and Regulations. Understands APUS SOPs, regulations/guidelines governing drug development (FDA, ICH, cGCP) and ensures that they are followed.
12. Training. Participates in on-going training and assists in the training of less experienced department members.
13. Other. Duties as assigned by supervisor.
Position Requirements: PhD or Pharm.D in Pharmacy or life sciences with extensive training in pharmacokinetics and pharmacodynamics and data analysis, i.e. biostatistics, pharmacometrics. Seven years of Research Data Science or Clinical pharmacology experience or equivalent. Knowledge of global drug development process and ability to design and implement PK/PD and/or Pop PK assessments within an integrated global drug development plan. Experience in providing strategic input to global clinical development plans. Extensive experience in representing Clinical Pharmacology to regulatory agencies.
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Lee Gellins
Executive Recruiter
FPC of Hilton Head
843 842-7221 x15
Lee@
MANUFACTURING ENGINEERING MANAGER—Litlle North of LA
Job Summary: Develops and manages engineering resources and efforts for new production programs for company and subsidiaries from the development and prototype stages through to final production stage. Provides technical supports to current production programs. This includes Planning/Business Award, Design, Prototype, Validation, Production Launch and Continuous Improvement.
Supervises: Engineering Teams, Tooling, and Maintenance
Job Duties and Responsibilities: Manage the direct responsibility for all engineering efforts for the personnel who report to the position. Direct responsibility for all Program Management activity and process improvement. Systems implementation, skill enhancement and standardization of policies and practices across the engineering group. Continuous management oversight on products in the development stage. Support design of new products and makes revisions as necessary. Communicates both internally and externally to ensure that projects are running per specifications in terms of cost, quality, and timeliness. Maintain close customer contact to resolve any production problems. Interfaces strongly with manufacturing to support existing product lines. Support the efforts to generates product quotations develop test methods and procedures as needed. Visits customers and vendors as required. Performs necessary functions to adhere to ISO13485, MDD, and FDA standards.
Qualifications: BS in Mechanical Engineering is required with added disciplines in business management a plus. Three to five years experience in managing engineering resources with systems design required. Working knowledge of silicon injection molding and extrusion processes preferred. Previous experience in product design, program management and launching products successfully. Computer literate with knowledge of spreadsheet and word processing packages, and Microsoft Project desirable.
This person should have experience training/mentoring engineers in high production medical device companies.
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Project Manager-
THE PROJECT MANAGER REPORTS DIRECTLY TO THE ENGINEERING MANAGER. THE INCUMBENT IS AN INDIVIDUAL CONTRIBUTOR, BUT WITH THE RESPONSIBILITY AND AUTHORITY TO LEAD MULTIPLE CROSS-FUNCTIONAL TEAMS. THIS POSITION IS RESPONSIBLE FOR MANAGING NEW PROTOTYPE DEVELOPMENT PROJECTS, AND ALSO NEW PRODUCTION LAUNCHES USING ESTABLISHED ADVANCED PRODUCT QUALITY PLANNING (APQP) PROJECT MANAGEMENT PRACTICES, WITH THE GOAL OF FLAWLESS LAUNCH OF NEW PRODUCTS TO PRODUCTION. PROJECT LEADERSHIP IS PROVIDED FOR ALL PRODUCT LINES MANUFACTURED AT THIS LOCATION OF COMPANY AND ITS SUBSIDIARIES. IN ADDITION, THIS POSITION IS ALSO RESPONSIBLE TO LEAD NEW PRODUCT COST-ESTIMATING AND TEAM FEASIBILITY REVIEWS FOR ACTIVITIES IN SUPPORT OF QUOTING NEW BUSINESS OPPORTUNITIES.
Job Responsibilities
• Provides leadership to manage multiple new prototype development projects, and also new production launches using established project management practices.
• Leads cross-functional teams of resources, drawing from other functional areas, to ensure on-time delivery and a flawless launch to production utilizing best-practices.
• Provides leadership to comply with, and maintains documentation in accordance with Quality System Requirements (QSR), FDA cGMP, internal procedures, customer requirements and notified body requirements.
• Measures, reports, and continuously improves performance metrics (KPIs) of the product development and launch process.
• Assists in development of design standards, cost standards and pricing standards to expedite and provide input for continuous improvement of the quote process.
• Develops accurate and timely manufacturing costs in response to customer or internal inquiries; create new work center costs as needed for cost calculations.
• Reviews, recommends, and directs the “make or buy” decision process.
• Maintains adherence to Company policies, safety/ergonomic standards and good housekeeping practices.
Required Qualifications
• BACHELOR’S DEGREE IN A RELATED TECHNICAL FIELD SUCH AS MECHANICAL ENGINEERING, CHEMISTRY OR PLASTICS ENGINEERING.
• Demonstrated experience providing leadership, managing multiple projects of medium complexity. Proficient in MS Project.
• 5 years minimum of related experience in the medical device industry.
• Working knowledge of ISO-13485 and FDA cGMP regulations.
• Strong business and economic acumen
• Proficiency in basic computer skills (Word, Excel, PowerPoint, etc.) Working knowledge of ERP/MRP software.
• Working knowledge of engineering terminology, extrusion and injection molding processes, tooling and validation protocols.
• Working knowledge of work centers, cost structure, and basic industrial engineering practices.
• Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and suppliers.
Preferred Qualifications
• Degree in biomedical or biomechanical engineering is preferred.
• Business degree or progress toward a business degree.
• PMP Certification in Project Management
• APICS certification
• Experience using QAD MFG/Pro ERP software
• Prior experience in a product cost-estimating role
• Lean Systems or Six-Sigma Green Belt Certification is a plus
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Please contact Cheryl Heinla at Cheryl.Heinla@ if interested.
I'm looking for a QA Associate I to work in support of biopharma
manufacturing/warehouse. Someone with a little experience in GMP, raw
materials, label & packaging inspection. Do you know any one on the
junior side from your past work experience who might be interested in
contract in the East Bay?
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Other Information for Those in Transition
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Upcoming Bioscience Business and Marketing Courses in the fall at UCSC Extension at the new location in Santa Clara near intersection of 101 and Bowers…please help us promote these courses beyond those who have taken them already. There’s little information about these courses developed specifically for working professionals in the life science industry. These two days of intensive classroom work followed by 2 months of work done at student’s home location allows for participants who come from outside the Bay Area on business and add on two days and take a top rated course from experts in the field at an affordable price.
October 8-9: BIOSCIENCE BUSINESS AND MARKETING ESSENTIALS
The bioscience industry is like no other. Lengthy timelines and unique financial, legal, regulatory, social and political challenges impose constraints that impact every aspect of the business. This course helps participants gain: a practical understanding of the bioscience industry landscape, key business drivers and challenges; insight into the critical roles that business and marketing disciplines play at all stages of a bioscience company's development; and hands-on experience implementing important bioscience business processes that are essential to success within the industry. Presented by UCSC Extension in Silicon Valley, Santa Clara, CA. For more information: See ucsc-extension.edu/biobusiness.
December 3-4, BIOSCIENCE BUSINESS DEVELOPMENT: BUILDING VALUE
UCSC Extension in Silicon Valley presents a two-day intensive course that brings the breadth of the Bay Area’s biobusiness development expertise to our Cupertino classroom. Whether financing start-up activities, trying to keep pace with the current burn rate, or moving a product into the marketplace, bioscience companies, both large and small, have a critical need for business development at every stage of their evolution. Learn the key roles that business development and licensing play in the commercialization of a new product and the development of a successful bioscience company. Santa Clara, CA. For more information, see ucsc-extension.edu/biobizdev
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Biotech Bay Career Fair, Tuesday Afternoon and Early Evening, Oct. 13, 2009
Event: Biotech Bay Career Fair
Location: San Francisco Airport Marriott
Date and Time: Tuesday, October 13, 2009; 2pm to 7pm
Click here for directions
Register at
Event Description
Positions in Biotech * Pharmaceutical * Medical Device & Diagnostics
Looking for a new job? Networking with industry peers in an ever-changing work environment?
Attend the Biotech Bay Career Fair!
Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Bay area.
Who should attend?
Candidates with a 4-year degree in the life sciences and a minimum of 2-years of industry related experience are invited to attend. Just register by clicking the button below.
(Equivalent work experience may be considered in lieu of a four-year college degree. PhD and Postdoc candidates welcome.)
What types of positions are available?
Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, biostatistics, clinical data management, chemistry, regulatory affairs, and research.
What companies will be there?
Scroll to the bottom of the pages to see a list of exhibiting companies. Take the time to research what each company is recruiting for to see if you are a match. Most companies will be from the Bay area, but some will travel from other regions to attract top talent! If you can’t make it on event day, you can still pre-register online to allow exhibiting companies to view your resume and contact you outside of the career fair.
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Job Sites
The most known site for career and job listings is which focuses on biotech and pharma.
A newer website which includes jobs but also a virtual exhibit hall for companies—this one is dedicated to pharma entitled at
There’s website with jobs specific to medical device area at the .
Another new site with listings of interns, consultants and some jobs is
I’ve just received information on another new site with sole focus on medical devices and most in the Bay Area is I’m told they had 97 placements last year. Check this one out and let me know if you have good results.
You can look up pharmaceutical jobs in your area by zip code at . They include all functions in pharmaceutical companies.
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Other Helps
I received Biotech Ink Insider from Susan Caldwell, a local medical writer. She always has great insights as well as jobs at times to share. I’ve pasted in some videos mentioned by Susan that might be of interest for your job search:
Writing a Resume: When seeking a job, the resume is of considerable importance--it's your calling card and door opener. Here's a video that helps you create the right resume and minimizing the stress while you do it. Includes ten rules for how to approach your resume, interview, and job search. Very good basic advice.
Writing Your Resume Cover Letter: Same instructor as for Writing a Resume (above). Gives good basic advice on how to craft your cover letter and get the job interview you seek.
The Art of Medical Writing: Short video on the Masters in Medical Writing program at the University of Philadelphia, the only such training program in the world.
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Susan Caldwell wrote an article regarding writing a resume as well.
10 Tips for Creating a Door-Opening Resume
by Susan E Caldwell
If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers.
As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions:
1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database.
Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance:
Introduction or Career Goal
Summary
Work History or Professional Accomplishments (if candidate has work history)
Academic Background
Skills
Honors and Awards
Publications
There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections.
When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization.
2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position.
3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume.
4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies.
5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny.
6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice.
The remaining points in this article address issues within your resume's sections:
7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what your want to do in your next job.
8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.)
A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous.
As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history.
9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility.
10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers.
Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.
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About the Author
Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008.
You can email Susan at caldwell@, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account).
Copyright 2009 Biotech Ink, LLC. All rights reserved.
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Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing.
As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order:
1.
2.
3.
4.
5.
6.
7.
8.
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See free downloadable annual Salary Survey from Contract Pharma at
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Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, , published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at .
This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search () and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities.
The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon.
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These job postings are listed on my blog accessed at along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@ if they wish to receive these mailings directly.
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