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| Job ID | Employer | Position | Description | Requirements | Location | Contact | Post Date |
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| Spherion On-site at Janssen Alzheimer’s Immunotherapy (temporary project through the end of 2010) |
Quality Control Manager/Analyst
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Spherion On-site at Janssen AI has an immediate need for a QC Manager/Analyst. Janssen AI is a newly developed Johnson & Johnson company of 125 employees developing therapies that enlist the body's immune response to treat and prevent Alzheimer's disease. Our pipeline includes a potential first-in class treatment, currently in late-stage clinical trials.
The QC Manager is directly responsible for the management of QC laboratory personnel supporting cGMP testing of drug substance material, drug product, and finished products, and stability testing. Will also oversee analytical activities performed by partners and/or Contract Research Organizations. Must be willing to perform bench work as a back-up for Research Associates.
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Qualified candidate will have a BS or MS in Chemistry, Life Sciences or related field. Candidates must be willing to perform laboratory studies as well as review and oversight. HPLC and cGMP experience a must. Should have at least 7 plus years experience with 2 years managerial experience in a Quality Control environment.
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South San Francisco
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Kathykuchac@spherion.com
| 3/8/2010 4:50:55 PM |
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Details>>
| Onyx Pharmceuticals |
Associate Scientist/Scientist Process Development
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The Process Development Scientist will design novel synthetic processes and optimize existing processes for transfer to contract manufacturing organizations (CMO). This position will be responsible for producing compounds for evaluation in preclinical safety and efficacy studies. This includes preparation of representative materials for testing, impurities for reference, starting materials, intermediates, and the write-up of development reports and technology transfer packages for CMO. This position reports to the Head of Chemical Development.
Specific duties include (but not limited to):
• Design and develop new routes and optimize existing processes, which includes the synthesis, purification and isolation of intermediates and bioactive lead compounds from milligram to multi-gram scales for use in R&D programs.
• Define the design space (NOR, PAR & EOF), determine important and critical process parameters, and optimize parameters for maximal performance with DOE studies
• Scale-up process to 100g+ to demonstrate process and trouble-shoot/facilitate implementation of manufacturing processes at CMOs, which include development and implementation of in-process controls.
• Perform preliminary solid form screening (e.g. polymorph, salt and co-crystal screening), and coordinate evaluation and selection of solid forms for lead compounds.
• Coordinate with Analytical, Pharmaceutical Development, and QC to identify and characterize impurities in chemical processes, synthesize reference materials and deliver drug substances to project teams in a timely fashion.
• Prepare technology transfer packages for transfer to CMOs and development reports to support regulatory filings.
• Interact with/support technical staff of CMO to implement transferred process.
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Thorough experience in handling, synthesis, purification, and characterization of complex organic molecules using the latest techniques is required. Prior experience in a kilo lab or pilot plant setting and familiarity with cGMP guidance, DOE studies, QbD and related methodologies are highly desirable.
• BS with 5+, MS with 4+ or PhD or equivalent degree in organic chemistry or the chemical sciences with 1-3 years working experience (postdoctoral may serve as experience) with small molecule or peptide process development
• Strong and independent problem-solving and troubleshooting abilities
• Basic knowledge and understanding of cGMPs
• Preparative chromatography and LCMS experience a plus
• Excellent oral and written communication skills
• Demonstrated track record of completion of development reports
• Ability to work independently and in a team environment
• A flexible, “whatever it takes” attitude
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South San Francisco
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www.onyx-pharm.com
| 3/5/2010 5:16:49 PM |
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Details>>
| Onyx Pharmaceuticals |
Associate Director/Sr/ Scientist
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We are seeking a talented scientific leader that embodies the entrepreneurial spirit and who will thrive in a fast-paced environment. The individual will lead a team providing in vitro and in vivo drug metabolism, absorption and pharmacokinetic characterization to support the discovery and development programs at Onyx Pharmaceuticals Inc. The candidate would have the qualifications and experience as listed below:
• Provide leadership in pharmacokinetic evaluation to support small molecule drug development.
• Manage the design, conduct and interpret in vitro and in vivo studies to assess metabolic liabilities, drug absorption and drug-drug interaction.
• Interact with CROs and monitor outsourced DMPK studies.
• Coordinate and interact with other departments
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• PhD in pharmaceutical science, pharmacology or related field.
• 8 – 10+ years of relevant industry experience in drug absorption, metabolism, excretion and pharmacokinetics to support drug discovery and development.
• Demonstrated management experience
• Hands-on experience in PK study design, PK modeling and reporting.
• Experience in bioanalysis using LC/MS/MS is a plus.
• Excellent oral and written communication skills.
• Excellent team leader
• Ability to work effectively with multidisciplinary project teams.
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South San Francisco
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www.onyx-pharm.com
| 3/5/2010 4:29:12 PM |
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| Formurex, Inc. |
Analytical Scientist
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Formurex, Inc. is a pharmaceutical contract research organization whose mission is to provide high quality service in preformulation, formulation development, stability, CTM manufacturing. We are seeking self-motivated scientists who will be responsible for providing analytical support.
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M.S. or Ph.D. in Pharmaceutical Analysis / Chemistry / Chemical Engineering, with 3-5 years experience in developing and validating analytical methods for drugs and pharmaceuticals.
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Stockton, CA
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hr@formurex.com
| 3/1/2010 11:07:43 PM |
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Details>>
| Theravance, Inc. |
QC Analyst, Analytical Development
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We have an immediate QC analyst position open in Analytical Development. This position will be working in a fast-paced analytical development team for the release testing of starting materials, intermediates, new drug substances, new drug products and related compounds and the development and validation of analytical methods in support of Product Development projects.
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Qualified candidate will have a Bachelors or Masters Degree with three to seven years’ extensive analytical QC experience. The candidate should be technically proficient in at least two areas of analytical development (compendia testing, separation sciences, spectroscopy and hyphenated technology), be able to accurately document experimental details, review and approve the work of others for accuracy and compliance. The candidate should be able to work independently and to multi-task effectively. Excellent oral and written communication skills are required. He/She should possess excellent knowledge of scientific principles, laboratory skills and laboratory safety and have extensive experience working in a GMP/GLP-compliance environment. The candidate will need to have an understanding of relevant project activities and provide substantial inputs for development documents such as technical reports, validation reports, IND’s, EDP’s, patents, etc. He/She should possess strong people skills and is capable of working in a team environment.
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South San Francisco
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careers@theravance.com
| 2/26/2010 10:35:42 AM |
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Details>>
| Aragon Pharmaceuticals |
Research Associate, Bioanalytical/In Vitro ADME
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Aragon Pharmaceuticals has an immediate opening for a Research Associate, Bioanalytical/In Vitro ADME. The successful candidate will support bioanalytical method development and analysis as well as in vitro ADME assays for research and development projects.
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The successful candidate will have a B.S. or M.S. degree in Biology, Chemistry, Biochemistry, Analytical Chemistry or related field with at least 2 years industry experience.
Direct, hands on experience with operation and troubleshooting of bioanalytical instrumentation (HPLC, LC/MS); extraction and analysis of small molecules in biological samples and matrices; experience with in vitro ADME methods (e.g. liver microsomes, hepatocytes, protein binding or permeability) a plus; experience with metabolite profiling and identification a plus.
Must work well in a team environment and have the flexibility to succeed in a dynamic, early phase, start-up; creative problem solving and excellent oral and written communication skills are a must.
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San Diego, CA
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jobs@aragonpharm.com
| 2/23/2010 5:59:29 PM |
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| Full Spectrum Analytics, Inc. |
Field Service Specialist,LC/MS
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Install and service analytical instruments.The ideal candidate will have a minimum of 8 to 10 years of field experience, with GC/MS and LC/MS service, 2 years manufacturing experience with analytical instrumentation and 2 to 4 years management or leadership experience.
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Requires a bachelor’s degree in Chemistry or Biology and 2-4 years experience in the field or in a related area.
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San Francisco / San Diego, CA
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hr@fullspectrum-inc.com
| 2/22/2010 12:54:38 PM |
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Details>>
| On Assignment, Lab Support |
Chemist II
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Conducts experiments without supervision and maintains laboratory
notebooks on these experiments. Prepares technical reports,
summaries, protocols and quantitative analyses.
Exercises technical discretion in the design, execution and
interpretation of experiments.
Demonstrates full command of the techniques and tools required for
their assigned responsibilities.
Manage day to day activities in the laboratory
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Help develop and qualify bioanalytical method to support skin
penetration studies
Perform Skin Permeation Assays, including handling of biohazardous
materials with focus on performing bioanalysis (HPLC and LCMS), and
compiling and analyzing data for Monthly Reports
Share data in discussion groups and team meetings.
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Silicon Valley, Peninsula
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Amy.Borchard@onassignment.com
| 2/22/2010 11:04:29 AM |
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Details>>
| ABC Laboratories, Inc. |
Senior Scientist, Group Leader
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The Group Leader will plan and manage the contracted activities of analytical development that supports client-driven method development and validation R&D projects. Will manage technical resources in the form of staff, equipment, and facilities to provide company's service to clients. Will coordinate activities for staff of 8-16 scientists to achieve expected technical and financial results to support client-driven projects, and will mange group financials and reporting.
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Ph.D. in specified study area with 2 years of relevant experience.
Master's degree (M. A.) or equivalent with 5 years experience
BS in specified study area plus 8 years related experience and/or training; or equivalent combination of education and experience.
Knowledge/experience desired:
Drug industry experience with drug development background
Supervisory/project management experience
GMP/ICH/OSHA/GLP environment experience.
ABC Laboratories is an EEO/AA Employer
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Columbia, MO
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www.abclabs.com
| 2/22/2010 7:36:57 AM |
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Details>>
| ABC Laboratories, Inc. |
Senior Chemist/Team Leader, Metabolism
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The Senior Chemist/Team Leader will be responsible for conducting and reporting of plant and animal metabolism and bioconcentration studies for product registration following regulatory testing under current GLPs, including the use of the Microsoft platform for communication, reporting, and data analysis. Also responsible for monitoring regulatory and technical changes, along with their incorporation and providing significant input to the marketing of these services. Will lead a team of 5-6 lab personnel (scheduling studies/time-off; assist in reviews, etc).
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Bachelor’s degree in technical or scientific field of study with 8 years of comparable laboratory experience.
Master’s degree in technical or scientific field of study with 5 years of comparable laboratory experience.
Ph.D in technical or scientific field of study with 2 years of comparable laboratory experience.
Knowledge/experience desired:
Experience in a contract laboratory environment
Experience working with 14C material
Experience in other E-fate and/or Product Chemistry testing (e.g., OECD 100 and 300 series.
ABC Laboratories is an EEO/AA employer.
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Columbia, MO
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www.abclabs.com
| 2/22/2010 7:34:25 AM |