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| Job ID | Employer | Position | Description | Requirements | Location | Contact | Post Date |
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| Ardea Biosciences |
Bioanalytical Scientist
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Ardea Biosciences currently has a Scientist position in our Bioanalytical section of our Translational Medicine Department. This position will perform bioanalytical LC/MS/MS method development, validation and sample analysis to quantify drugs and metabolites in biological matrices under GLP and non-GLP guidelines.
Responsibilities
• Develop and validate LC/MS/MS methods for the quantitation of drugs/metabolites in biological matrices under GLP and non-GLP guidelines.
• Maintain, operate, and troubleshoot API4000 and API5000 LC/MS/MS instruments and other analytical equipment.
• Study and recommend new techniques in sample purification, analysis, and automation.
• Write and revise departmental SOPs, validation and analytical reports.
• Ensure adherence to protocols, SOPs and GLP guidelines.
• Analyze technical data to draw conclusions.
• Assist in the preparation of any regulatory submissions.
• May provide training to new and less experienced departmental staff.
• Maintain research records and lab notebooks in a concise, legible and complete manner.
• May serve as study director/principal investigator with responsibility for study binder review.
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• B.S. or M.S. in Analytical Chemistry or other related disciplines.
• At least two years of CRO or industrial hands-on experience in bioanalytical method development/validation and sample analysis using LC/MS/MS techniques.
• In-depth knowledge of LC/MS/MS techniques and sample preparation are a must.
• In-depth knowledge of GLP guidelines.
• Prior experience serving as a study director/principal investigator is a plus. This experience includes development of study protocols, SOPs, validation and analytical reports; preparation and/or review of study binders ensuring compliance.
• Strong communication skills, as well as the ability to be a team player.
If this sounds like a role for you, please apply at:
http://www.ardeabio.com/careers/
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San Diego
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http://www.ardeabio.com/careers/
| 7/29/2010 3:46:26 PM |
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Details>>
| SRI International |
Supervisor - Analytical Chemistry
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The Supervisor will provide analytical expertise and leadership supporting nonclinical safety studies conducted under Good Laboratory Practice regulations. The Supervisor will collaborate closely with other nonclinical development team members including formulation development, dose preparation, toxicology, pharmacokinetics, project management, and quality assurance.
The Supervisor will be asked to:
- Provide input in analytical method development, verification, validation, analysis of data, research techniques, and problem solving.
- Monitor the generation of analytical data, ensure appropriate and current test methods are used, and critically evaluate the validity of results.
- Write reports and respond to QA audits of raw data and reports.
- Supervise GLP analytical chemistry services and staff, write and review proposals and protocols, develop budgets for project tasks.
- Ensure adherence to SRI policies and quality programs.
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PhD (>5 years) in chemistry or equivalent with coursework in Analytical Chemistry. Experience with GLP and/or cGMP regulations and supervisory experience desirable. Excellent oral and written communication and interpersonal skills and ability to work in fast paced team environment.
Post-offer, pre-laboratory physical examination will be required.
About SRI:
SRI International is a leader in the development of new products for the treatment and diagnosis of disease, primarily in the areas of cancer, infectious disease, neuroscience, and immunology. SRI's Biosciences Division works in several ways, conducting basic research like an academic institution, performing drug discovery and biologic development like a biotechnology company, and carrying out preclinical development and pharmaceutical services like a contract research organization - from "Idea to IND" (tm).
The Biosciences Division works with partners and clients on a broad range of preclinical discovery and development projects, utilizing its expertise in medicinal chemistry, custom organic synthesis, efficacy pharmacology and safety evaluation, pharmacokinetics and metabolism studies, analytical chemistry, formulation design, drug product manufacturing, project management and regulatory affairs. Many studies are conducted under FDA's GLP and GMP regulations. SRI currently has several drugs on the market, several more in clinical trials, half a dozen in preclinical development, and has assisted in the development of more than 130 other products that made it to clinical trials or reached the market.
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Menlo Park, CA
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Apply via our web page www.sri.com/jobs to job number 100559.
| 7/28/2010 1:58:38 PM |
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Details>>
| Helicon Therapeutics |
Scientist
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Helicon Therapeutics is seeking a Bioanalytical Chemistry Scientist experienced in quantitative bioanalysis of plasma and other biological matrices to support pharmacokinetic and in vitro ADME analyses of novel small molecule therapeutics. The successful candidate will have strong technical expertise in bioanalysis using LC-MS/MS systems and other bioanalytical methods (UV, fluorescence, etc.). Expertise in in vivo and in vitro pharmacokinetics is required, with a strong background in modeling of pk data using compartmental and noncompartmental models.
Primary responsibilities include developing bioanalytical LC-MS/MS methods for the quantitative analysis of small molecule drugs, quantitating drug concentrations in various biological matrices, modeling of pk data. The successful candidate will also establish and validate various in vitro metabolic stability, cytochrome P450 and other DMPK assays. Experience with cell culture, automation platforms and permeability studies are a plus. The ability to work independently and manage research associates is required as are good communication and presentation skills
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• PhD degree in bioanalytical chemistry and 2+ years of industrial experience
• Extensive knowledge of DMPK science and experience in applying DMPK concepts to drug discovery and drug development
• Strong expertise in theoretical and practical pk concepts and ability to accurate model in vivo and in vitro data
• Experience in developing and troubleshooting LC-MS/MS methods and instrumentation
• Good organizational, record keeping, presentation and communication skills
• Enthusiasm and motivated team player with a can-do attitude
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San Diego, CA
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rmenezes@helicontherapeutics.com
| 7/16/2010 12:54:54 PM |
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Details>>
| Relypsa |
Temporary Analytical Development Scientist
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• Develop, qualify and validate analytical methods for release and stability testing
• Evaluate and improve existing analytical techniques and assays
• Conduct routine analysis following SOPs
• Troubleshoot instruments and software issues
• Review/write analytical test methods, protocols and reports; interpret/present analytical data
• Coordinate analytical activities at CRO and CMO (tech transfer, stability coordination, data review)
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• PhD degree in Analytical Chemistry, or related disciplines with 5+ years in analytical function supporting drug development. BS and MS degree with 10+ years experience will also be considered.
• Hands-on experience in more than one of the following techniques is a must: LC, LC/MS, Ion Analysis Methods, GC, GC/MS, GPC/SEC, solid state IR, NMR, XRD, XPS, DSC, TA and Light Scattering
• Experience with providing rapid turn-around analytical support to process and formulation development (e.g. in-process monitoring, early impurities assessments, excipient compatibility, bio-equivalency studies, etc.) is required
• Ability to exercise independent judgment in developing methods and evaluation criteria for obtaining results is desired
• Excellent working knowledge of the ICH Guidelines regarding Quality and Stability Testing, GMPs and GLPs and other regulatory requirements from IND stage to NDA filing is a plus
• Strong communication and interpersonal skills for a team-oriented environment is required, along with the ability to be flexible and collaborate on projects.
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Santa Clara, CA
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apply-sn005@relypsa.com
| 7/15/2010 11:07:28 AM |
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Details>>
| Pfizer |
Drug Metabolism-enzymologist
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Design, coordinate and may execute necessary in vitro studies to characterize metabolism and absorption attributes of new chemical entities (NCE), and to mitigate metabolic and absorption liability risks. Provide expertise in the design of mechanistic/kinetic metabolism and drug interaction studies to support discovery and development projects. Highly matrix environment, extensive collaboration and teamwork with PDM department with project representatives, biotransformation, in silico, bioanalytical and across research lines.
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Training and Education Preferred:
-PhD in Pharmaceutical Sciences/Drug metabolism or related discipline with 3+ years of industrial experience. Experience working in an industrial discovery and/or development environment on identification and development of NCE, with an emphasis on understanding drug metabolism and enzyme kinetics.
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La Jolla, CA
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www.pfizer.com, job posting # 940933
| 7/14/2010 9:52:35 AM |
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Details>>
| Portola Pharmaceuticals, Inc |
Protein Analytical Scientist - Temporary Assignment
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The Analytical Development group is seeking a temporary assistance (6-month assignment) with establishing, developing, and/or optimizing analytical methodology to test the identity, purity, potency and stability of protein products (in-process and final). Help with troubleshooting established test methods used in development and release testing. Provide analytical support in troubleshooting process and formulation problems. Manage CRO in method transfer, assay qualification/validation, lot release and stability testing of protein API and formulation. Take part in writing CMC section for IND.
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We require that you have –
• Ph.D in Analytical Chemistry or related field.
• MS/BS with extensive relevant experiences will also be considered.
• Minimum 5 year experiences in analytical laboratory in pharmaceutical industry.
• Proven experience with method development and validation in a cGMP setting.
• Hands on experiences with HPLC, SEC, IEX, IEF, Gel electrophoresis, ELISA, Western blot, and other state of the art analytical methodologies for protein quantitation and characterization. Be able to execute and troubleshoot a variety of methods used for analysis and characterization of proteins.
• Hands on experience with mass spectrometry for protein characterization is a plus.
• Excellent oral and written communication skills
• You are able to work safely in an analytical/bio-analytical laboratory with inherent safety concerns such as chemicals, glassware, infective agents, etc.
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South San Francisco, CA
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careers@portola.com
| 7/9/2010 8:10:35 PM |
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Details>>
| Genentech |
Senior IMP Quality Product Steward Small Molecules
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For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to develop novel medicines for serious and life-threatening diseases. Now a wholly owned member of the Roche Group, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset.
The following opportunity exists in our South San Francisco, CA, headquarters:
Senior IMP Quality Product Steward Small Molecules
Responsibilities:
The Senior IMP Quality Product Steward Small Molecules will be responsible for product quality and the single point of contact for the GMP quality organization for small molecule products. The Quality Steward oversees every aspect of the GMP quality system throughout process development and regularly receives and provides input and feedback from site and corporate Quality groups regarding product quality. The individual is the GMP quality decision-maker for product-impacting decisions such as product specific change requests and the outcome and CAPAs associated with product-impacting investigations. He/she approves the shelf life and specifications for the products and drafts, approves and maintains product specification files. In addition, the incumbent captures relevant technical information, regulatory inputs, as well as considerations for cross-project consistencies and oversees the quality aspects of combination products like devices. The individual will initiate, champion and drive quality projects and act as advisor to senior management.
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This position requires a Bachelor’s or Master’s degree in science or a technical discipline and at least 15 years of experience in pharmaceutical companies with at least five years of experience in Quality. A PhD is preferred. The ideal candidate will be a recognized leader who leads others especially in the times of uncertainty and an effective communicator of ideas which have a major impact on directives and goals. The applicant must have at least three years of increasing management responsibility or consulting experience. He/she must be knowledgeable of US, Canadian, EU and ROW regulatory requirements applicable to development and production of bulk recombinant proteins, combination products, including devices to be used for clinical trials.
Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: http://careers.gene.com and reference Req. #1000032812. Please use “Web – CACO” when a source is requested. Genentech is an equal opportunity employer.
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South San Francisco, CA
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http://careers.gene.com
| 6/29/2010 1:28:29 PM |
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Details>>
| Medi-Lab |
Lab Technician
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We are a new forensic toxicology lab and are currently looking for someone who has knowledge working with LC-MS/MS (specifically Shimadzu-LC and API 3000-MS). Job duties would include creating Methods for Drugs of Abuse testing.
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Prior experience in writing Methods for LC-MS/MS. This position would be on a consulting bases affording flexibility in ones schedule.
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Los Angeles
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chris@pogosyaninc.com
| 6/17/2010 4:54:57 PM |
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Details>>
| Amyris |
Research Technician
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As a research technician in our analytical chemistry group, you will receive samples for analysis and then provide analytical results to our research groups by operating automated-instrument-based techniques for chemical identification and quantification. You will accept samples from the research staff and maintain a schedule of the tasks to be performed under the direction of an analytical chemistry supervisor. You will use automated GC and HPLC equipment with software tools to analyze compounds produced from cell cultures. You will process the analytical results for timely reporting to the various research groups. The research technician will prepare calibration standards, perform routine maintenance on analytical instrumentation and perform standard QA/QC procedures. The research technician will also be responsible for maintaining certain supplies and perform laboratory housekeeping tasks. The research technician will maintain some laboratory records and notebooks. The research technician may also participate in development and evaluation of new analytical methods, instruments and techniques.
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• B.S. degree in chemistry or related discipline
• Experience in instrumental analysis, including: operation, troubleshooting, and maintenance of analytical instrumentation, especially HPLC, GPC, and GC is required
• Knowledge of analytical software, e.g., Excel, Agilent Chemstation, Dionex Chromeleon is required
• Ability to work Friday through Tuesday is required
• Experience with automated Karl Fischer titration apparatus is a plus
• Experience with automated ICP-optical emission spectroscopy is a plus
• Experience in sample analysis from environmental or biological matrices is a plus
• Experience with statistical quality control of laboratory data is a plus
• Requires strong time-management and multi-tasking skills
• Requires collaborative teamwork, communication and data handling skills
• Energetic, highly self-motivated and able to work efficiently and productively in a start-up company environment.
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Emeryville, CA
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hr@amyris.com
| 6/11/2010 9:29:17 AM |
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Details>>
| Amyris |
Quality Assurance Manager
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We are seeking a highly-motivated and collaborative quality assurance manager to develop and implement quality systems across global sites in both research and manufacturing. The quality assurance manager will be responsible for: (1) ensuring alignment of in-process and final product assays with specifications, (2) leading the investigation of and correcting non-conformances, (3) implementation and upkeep of appropriate quality tracking records, and (4) as necessary grow and develop the quality assurance group to match company growth. The successful candidate will have significant leadership experience and excellent cross-functional communication skills in interfacing with multiple groups. In addition, experience interfacing with external collaborators to support manufacturing and scale-up activities is required.
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Responsibilities:
• Develop and implement quality systems across manufacturing and research sites.
• Ensure alignment of product testing procedures with customer requirements and governmental regulations to ensure delivery of product that meets specifications, including oversight for quality agreements with external vendors and collaborators.
• Identify, investigate, and coordinate responses to internal and external non-conformances within the quality system.
• Maintain appropriate quality tracking records (certificates of analyses, control charts, calibration records etc.).
• Periodically participate in the review of existing and proposed specifications, standard operating procedures, and manufacturing batch records.
• Approve disposition of product as necessary to support business development.
• Advise business development on quality issues regarding new products and partnerships.
• Advise personnel in reviewing technology, methods, equipment, and facilities with respect to their quality assurance aspects.
• Develop a QA program for employee training in manufacturing quality control.
• Oversee development of QA employees for maximum effectiveness, including training and coaching.
Requirements:
• Bachelor’s degree in chemistry or related discipline is required.
• Knowledge of industrial fermentation processes is a plus.
• 5+ years QA/QC experience, including process validation and technology transfer in a manufacturing environment.
• Demonstrated leadership skills and experience managing outcomes through others to accomplish goals.
• Strong ability to evaluate processes and to lead effective change.
• Excellent cross-functional collaboration, communication, and interpersonal skills are required.
• Energetic, highly self-motivated and able to work efficiently and productively in a rapidly-growing company.
• Proficiency in writing and oral presentations.
• Demonstrated ability to negotiate conflicting points of view across business functions.
• Ability to travel as needed approximately 25-35% of time.
• Demonstrated experience with statistical process control methods and software packages.
• ISO9000 corporate qualification and compliance experience is a plus.
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Emeryville, CA
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hr@amyris.com
| 6/11/2010 9:27:38 AM |