SF Bay Area biotech / science jobs - tribe.net

Medical Technologist – Medical Device Clinical Studies

2009-03-13T16:38:41Z

The selected candidate will work on a project and perform clinical studies in a start up mode, monitoring and close out for a new medical device which will automate blood glucose testing. You must be able to frequently travel to multi-state study sites to monitor the clinical trial progress. You must have the skills necessary to calibrate, maintain and troubleshoot lab systems. Qualifications include a degree in Medical Technology with several years experience in clinical trials. You must be willing to travel for at least fifty percent of the time during the study and possess the necessary technical ability to calibrate, maintain and troubleshoot lab systems. Please note that this is a contract opportunity for approximately 6 months in duration. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Location: San Jose - 2715 views

Senior Scientist/Associate Director DMPK

2008-12-01T22:24:21Z

The selected candidate will be responsible for enabling the discovery and development of safe and effective medicines by elucidating the absorption, distribution, metabolism, excretion, and pharmacokinetic properties of small molecule drug candidates. Through individual contributions as well as through leading other scientists, the successful candidate will ensure project teams receive quality, timely and appropriate support from the DMPK discipline to enable rapid selection and progression of high value compounds into full development. This is accomplished through the application of state-of-the-art technologies and sciences of bioanalysis, drug metabolism, drug transport, and pharmacokinetics. You will also work closely with teams in medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology, and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation, and contribute to IND and NDA filings. Qualifications include a Ph.D. in a DMPK discipline with eight plus years of previous experience in the pharmaceutical industry and in the DMPK discipline. You should have thorough knowledge of DMPK principles and GLP guidelines. Experience working with regulatory filings and FDA interaction is desired. You should also have strong leadership attributes and the proven ability to influence cross-functional drug discovery project team members. You may manage a group of research staff. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Hayward / Castro Valley - 5944 views

Senior Scientist/Associate Director DMPK

2008-10-28T18:33:37Z

Full Time -

Location: Hayward / Castro Valley - 4924 views

Associate Director/Director of Quality Assurance

2008-08-26T22:26:54Z

The selected candidate will be responsible for designing, implementing, and managing Quality Systems both internal and external to achieve compliance with SOPs, cGMP, and guidelines. You will be responsible for interface with other internal departments, along with external suppliers and contractors, to ensure the release of clinical trials and comply with all regulatory requirements. Your main functions are to understand and interpret regulations and guidance documents related to pharmaceutical drug product, design and manage the implementation of Quality Systems, including training, document archives, deviations/ incidents, investigations, CAPA, and change control, Establish metrics to assist in evaluating effectiveness of Quality Systems, write, review, or approve company SOP’s, review master documents for compliance with cGMP, quality systems, and other related documentation, approve specifications, test methods, stability protocols, and associated documentation related to clinical trials and commercial products, manage internal and external audit programs, drive process improvement initiatives to maximize resources; provide critical input, and manage the development and maintenance of a global QA system, and manage the development of QA policies, guidelines and associated documents prior to approval, review and approve clinical research documents such as study protocols, patient informed consent forms, and clinical/ nonclinical study reports, to assure that these documents conform with regulatory standards and SOPs/ procedures, manage FDA and industry compliance standards and trends to assure an appropriate compliance program, provide periodic reports to management of overall compliance trends and suggests appropriate process improvements. Provide compliance, strategic, and policy guidance to management. Qualifications include a BS or MS degree in a relevant scientific discipline with 10 or more years of experience in the pharmaceutical or biotechnology industry, including QA auditing and management experience. You should have strong GCP and GLP QA experience. Excellent written and oral communication skills and the ability to operate effectively in a team environment are required. You should be able to demonstrate the ability to delegate, develop and implement business processes and process improvements. This position may also be available to candidates at the Director level. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Hayward / Castro Valley - 717 views

Senior Scientist/Associate Director DMPK

2008-08-26T22:24:19Z

The selected candidate will be responsible for enabling the discovery and development of safe and effective medicines by elucidating the absorption, distribution, metabolism, excretion, and pharmacokinetic properties of small molecule drug candidates. Through individual contributions as well as through leading other scientists, the successful candidate will ensure project teams receive quality, timely and appropriate support from the DMPK discipline to enable rapid selection and progression of high value compounds into full development. This is accomplished through the application of state-of-the-art technologies and sciences of bioanalysis, drug metabolism, drug transport, and pharmacokinetics. You will also work closely with teams in medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology, and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation, and contribute to IND and NDA filings. Qualifications include a Ph.D. in a DMPK discipline with eight plus years of previous experience in the pharmaceutical industry and in the DMPK discipline. You should have thorough knowledge of DMPK principles and GLP guidelines. Experience working with regulatory filings and FDA interaction is desired. You should also have strong leadership attributes and the proven ability to influence cross-functional drug discovery project team members. You may manage a group of research staff. We will also consider candidates at the Associate Director level provided your background fits the profile above. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Hayward / Castro Valley - 741 views

Biotech / Pharmaceutical Job

2008-06-22T18:41:58Z

Biotech Job / Career Description: We are currently seeking a Biotech Professional for a world-class / featured Biotech employer with a location in your area. The company is seeking a skilled professional to fill a regular full-time position. All positions represented offer benefits and an opportunity for advancement. A strong background in Biotechnology, Biology, Pharmaceuticals, or Chemistry is generally required for this position and for all positions and companies we represent. Experience: Previous relevant experience is required, along with any required training, education, etc. The ideal candidate will have the ability to take initiative, work independently and in a team setting, and multi-task effectively. Desired Skills: Previous Biotech experience with one or more of the following is required. Biological Scientist, Clinical Lab Technologist, Research Scientist / Associate, Medical Scientist, Lab Technician / Associate, Sales, Marketing, or General and Administrative. Apply: To apply online, please email your resume and additional information directly to the employer's email address or resume submittal form. This information is available on the featured employers page at: www.eBiotechCareers.com

Full Time -

Location: SF Bay Area - 10021 views

Senior Scientist - Immunodiagnostics

2008-04-24T17:46:27Z

The selected candidate will join the Clinical Diagnostics group and will be responsible for initiating and investigating scientific concepts related to the fulfillment of company long term goals. This position involves review and interpretation of scientific literature, laboratory investigations, project planning and interaction with other departments as needed to support company goals. Working independently, you will develop, design and perform experimental strategies and procedures for projects; conduct, direct and troubleshoot potentially highly complex technical experiments. You will also evaluate ideas which can lead to new or improved products or processes. Qualifications include a Ph.D. in Biochemistry, Immunology or a related scientific discipline or a Masters degree with a minimum of 3 years of R&D experience. You must be able to effectively communicate and interact with others and do hands on work in the laboratory. Position requires knowledge and skill in operating automated clinical chemistry analyzers with an emphasis in enzyme assay development. Candidate will have demonstrated success in technical proficiency, scientific creativity and independent thought. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 1082 views

Regulatory Affairs Manager

2008-04-24T17:44:03Z

The selected candidate will establish group priorities and insures that timelines are met. Prepares or coordinates Regulatory filings in the US and other countries. Acts as a liaison between other departments regarding current FDA regulations and operating procedures. Researches and determines applicability of changes in FDA regulations. Submits to FDA all required licenses and reports as needed. You will perform regulatory review of company product performance characteristics and determine regulatory strategy for new products. Prepares FDA 510(k), Japanese and European submissions. Acts as liaison between other departments regarding current FDA regulations and operating procedures. Provides information to external customers and other miscellaneous activities. Implements changes in labeling as per FDA, Marketing, or other department request. Reviews customer complaints for compliance and assesses whether corrective and preventative action is required. Reviews and approves PCOs for Regulatory Assessment. Reviews CE Mark and “add-to-file” technical files for completeness and accuracy prior to FDA submission. This position has the authority to submit Regulatory documentation to the FDA, and serve as the primary company contact for FDA submissions. Acts independently to determine methods and procedures on new assignments. Qualifications include a minimum BA/BS degree in a scientific related field with a minimum of 3-5 years related experience within the IVD “In Vitro Diagnostics” industry and/or training or equivalent combination of education and experience. You must be able to write clear, understandable technical documentation, i.e. regulatory documentation or scientific presentations. Ability to follow and give clear written and verbal directions with a high level of accuracy. Skilled at analyzing data and summarizing results. This position may supervise junior employee’s. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 517 views

Quality Control Chemist

2008-04-10T21:53:09Z

Using standard operating procedures and good manufacturing practices, you will be responsible for conducting routine and non-routine analysis of incoming raw materials, work-in-process materials and/or matched kits and filled bottle reagents. Perform initial troubleshooting of issues which arise during routine analysis. Document test results, problems and other relevant information under cGMPs. Perform simple revisions and updates to SOPs as necessary. Participate in interdepartmental meetings. Perform other responsibilities to support the needs of the department as assigned by Supervisor. Qualifications include a BA/BS in Biochemistry, Chemistry or closely related with 0-2 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry. Strong laboratory skills including pipetting, safety, and hazardous chemical handling. Understanding of cGMP and how it applies to the work environment is preferred. High level of reading comprehension skills. Ability to follow written and verbal directions with a high level of accuracy. Must be able to write clear and understandable documentation. Manual dexterity, must be able to lift/move up to 20 pounds. Intermediate word processing and spreadsheet software skills. Ability to manage multiple tasks simultaneously. Ability to perform simple data analysis and to summarize results. Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 1697 views

Technical Support Representative - Clinical Diagnostics

2008-04-10T21:46:44Z

The selected candidate will provide customers and end users with product and technical support. You will respond to customer inquiries on the telephone, through on-line networks or by mail or fax. Willingness to return customer calls after office hours rotating with other Tech Support Reps. Communicates with customers to help them understand how to use the product properly. Handles customer problems that appear to arise from the use of the product. Handles requests for replacing defective products. Completes, maintains and processes pertinent paperwork and records. Provides periodic reports to management including product compilations, suggestions and trend analyses. Maintains a current source of reference material, articles, and technical manuals as required to provide current information. Reviews available technical literature to maintain an awareness of current methods and systems. Performs services for departments, customers and OEM partners. Makes recommendations to, negotiates with and influences actions of other departments, customers and OEM partners. Qualifications include a BA/BS degree in Chemistry, Medical Technology or Immunology with 2-4 years related experience or equivalent combination of education and experience. Excellent written and verbal communication skills are required. Working knowledge of Windows based spreadsheets, word processors and database management software. Familiarity with scientific and clinical laboratory terminology and testing. Ability to understand basic chemistry and chemical reactions. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 1719 views

Scientist I - Assay Validation

2008-03-27T21:27:56Z

The selected candidate will provide overall support and assistance in the development and performance of enzyme immunoassays. This includes formulation of new reagents, enhancements of existing reagents and system evaluations. Work independently, as part of a team, on small projects. Receive general instructions on assignments with frequent review of results. Plan and conduct experiments for the evaluation of new or existing immunoassays using automated clinical chemistry analyzers. Organize, analyze and present data relevant to the assays performance. Qualifications include a BS in Molecular Biology, Biochemistry, Immunology or related scientific discipline with 0-2 years of laboratory experience. Proficient in Microsoft Excel and Word. Recombinant DNA, immunoassay or assay development experience a plus. Please note that this is a project specific opportunity for approximately six months in duration. Recent college graduates are encouraged to apply. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 1416 views

Quality Engineer/Supervisor/Manager

2008-03-25T21:36:40Z

The incumbent will be responsible for evaluation of company Quality Systems, including processes involving site compliance for ISO 13485, CMDR and FDA Quality System requirements. Position helps assure the appropriate Quality Systems are effectively implemented to comply with regulations. You will develop and prioritize an auditing schedule and perform internal quality audits in support of ISO, CMDR and FDA Quality System regulations. Exercise good judgment within defined procedures and practices to evaluate appropriate corrective and preventive actions. Expedite closure of internal and external audit observations. Assess closure of audit observations for timeliness, completeness of root cause, corrective action and preventive action. Prepare and distribute Quality Reports which include graphical analysis of auditing activities. Facilitate educational training sessions to communicate key Quality System information, including ISO, CMDR, and FDA Quality System training. Perform supplier quality audits in support of ISO, CMDR, and FDA Quality System requirements. This position has the authority to request additional documentation or further clarification from Process Owners to complete responses to audit observations. Participate in external audit activities as directed. Qualifications include a BA/BS degree or equivalent in a related field. The ideal candidate will have 5-7 years with ISO, CMDR and FDA Quality System Regulation in an IVD/Medical Device environment. Expertise with CAPA, SCAR, Complaint handling and NCAR is required. You should have knowledge and experience of the regulatory requirements pertaining to cGMP and ISO 13485. Able to use Microsoft Office tools (Word, Excel, Access). Strong organizational skills, detail oriented, ability to meet deadlines and handle multiple projects. Excellent written and oral presentation skills. Must exhibit professionalism, be pro-active, an advocate for change and self motivated. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 3699 views

Biotech - Scientist / Assoc / Tech / Lab / Med

2008-03-17T20:03:38Z

Biotech Careers – Targeted Resources, Full-time, Experienced, Management, Entry Level, Internship. Biological Scientist Clinical Lab Technologist Research Scientist / Associate Medical Scientist Lab Technician / Associate Biotech Sales, Marketing, Business Visit: www.eBiotechCareers.com Keywords: chemistry biotechnology microbiology research physiology science biochemistry pharmaceutical

Full Time -

Location: San Jose - 1248 views

Quality Systems Specialist

2008-03-06T21:03:01Z

The selected candidate will be responsible for evaluation of company Quality Systems, including processes involving site compliance for ISO, CMDR and FDA Quality System requirements. Position helps assure the appropriate Quality Systems are effectively implemented to comply with regulations. You will develop and prioritize an auditing schedule and perform internal quality audits in support of ISO, CMDR and FDA Quality System regulations. Exercise good judgment within defined procedures and practices to evaluate appropriate corrective and preventive actions. Expedite closure of internal and external audit observations. Assess closure of audit observations for timeliness, completeness of root cause, corrective action and preventive action. Prepare and distribute Quality Reports which include graphical analysis of auditing activities. Facilitate educational training sessions to communicate key Quality System information, including ISO, CMDR, and FDA Quality System training. Perform supplier quality audits in support of ISO, CMDR, and FDA Quality System requirements. This position has the authority to request additional documentation or further clarification from Process Owners to complete responses to audit observations. Participate in external audit activities as directed. Qualifications include a BA/BS degree or equivalent in a related field. The ideal candidate will have 5-7 years with ISO, CMDR and FDA Quality System Regulation in a medical device, biotechnology or pharmaceutical environment. Able to use Microsoft Office tools (Word, Excel, Access). Strong organizational skills, detail oriented, ability to meet deadlines and handle multiple projects. Excellent written and oral presentation skills. Must exhibit professionalism, be pro-active, an advocate for change and self motivated. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 2178 views

Technical Support Representative

2008-03-05T21:53:49Z

Full Time -

Location: Fremont / Union City / Newark - 2185 views

Enzyme Formulations Chemist

2008-03-05T21:50:08Z

The selected candidate will perform enzyme conjugations according to established protocols, including preparation, purification and final testing of assay performance to determine the effectiveness of the conjugate. Responsible for the formulations of enzyme and antibody bulk reagents, which includes the optimization of antibody and enzyme reagent bulks to achieve performance within a predetermined range of separation between established protocols. Prepare calibrators and controls according to specified protocols. Prepare buffers and other secondary solutions, which are used in various production processes. Qualifications include a BS degree in Biochemistry, Chemistry or closely related with 0-3 years experience. The ability to communicate effectively with both co-workers and other departmental personnel, specifically QA and R&D. The incumbent will work on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 1045 views

Clinical Manufacturing Chemist

2008-03-05T21:46:31Z

The selected candidate will manufacture clinical products and complete associated documentation. You will contribute to the transfer of new products into Product Production. Manufacture products using cGMPs. Review and approve completed batch records. Maintain and analyze lot histories for trends and discrepancies. May write, review, and modify SOPs, work instructions and reports. Maintain, troubleshoot and validate equipment as appropriate. Keep department lead or manager updated on all issues. Qualifications include a BA/BS degree in Biochemistry or Chemistry with 0-3 years related experience and/or training preferred. You should possess basic lab skills and knowledge of safety precautions. Familiarity with Quality System Regulations is preferred. Experience working with potentially hazardous chemicals and human source materials is preferred. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 824 views

Scientist II - Immunodiagnostics

2008-03-05T21:44:39Z

The selected candidate will provide technical support and assistance in the development and performance of in-vitro medical diagnostic products. This includes formulation of new and enhancement of existing quality control products. You will work independently, as part of a team, on small projects. You will plan and conduct experiments for the evaluation of new or existing products. You will organize, analyze and present data relevant to performance and stability. You may participate in writing or revising SOPs and reports. You will also interact with QC, Manufacturing and Technical Service groups. Qualifications include a BA/BS degree in Chemistry, Biochemistry or a related scientific discipline with 1-5 years of industrial laboratory experience or a recent MS Degree in Chemistry or Biochemistry. You should be proficient in MS Excel, Word and Powerpoint. Previous formulations experience with diagnostic reagents is a plus. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 379 views

Analytical Chemist - Methods Development

2008-03-05T21:41:43Z

The selected candidate will be primarily responsible for the method development and validation testing of finished products and raw materials. You will perform a variety of analytical chemistry processes such as potency assay, content uniformity and impurities testing by HPLC under instructions. You will also be involved in the development of stability indicating HPLC methods, validation of HPLC methods, support ANDA using the following techniques GC, IR, UV, TLC and/or other wet chemistry techniques. You will follow work instructions under GMP guidelines and perform other tasks as needed in the R&D lab such as stability and in-process sample testing. Qualifications include a minimum of a BS degree in Chemistry or closely related with one year experience, or an MS degree, in a science related field with an emphasis in Chemistry preferred. Other fields such as Biology majors with equivalent chemistry background may also qualify. You must have strong mathematical skills and a knowledge and commensurate experience in wet chemistry techniques such as: HPLC, GC, UV, IR, TLC and other instrumental techniques preferred. Knowledge of FDA guidelines, USP & GMP procedures are preferred. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other opportunities, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Hayward / Castro Valley - 455 views

Quality Control Technician - Immunohistochemistry

2008-02-22T18:31:14Z

The selected candidate performs specific laboratory procedures as requested by QC Lab Manager such as day-to-day immunohistochemistry (IHC) testing and product IHC stability tests according to established procedures/permanent work instructions. Assists in maintaining positive control slide product inventory and ordering. Prepare the required quality documentation on assigned quality control tests and/or assigned assays and processes. Release product as directed by QC Lab Manager. Complies with GMP, QSR and ISO regulations and quality policies and procedures. Qualifications include a minimum BA/BS degree in one of the Life Sciences. Able to perform all specific laboratory procedures as directed. You should have the ability to meet deadlines and ensure successful product release in a timely manner. Must be able to write clear and understandable documentation, have good attention to detail and be able to work in a team environment. A good understanding in antibody functions and structures is a plus. Please note that this is a project specific opportunity on contract for approximately 3 months in duration. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this opportunity or to preview other openings, please visit our website at: http://www.genquestbio.com/careers.htm

Location: Fremont / Union City / Newark - 453 views

Scientist II - Immunodiagnostics

2008-02-22T18:26:58Z

The selected candidate will provide technical support and assistance in the development and performance of in-vitro medical diagnostic products. This includes formulation of new and enhancement of existing quality control products. You will work independently, as part of a team, on small projects. You will plan and conduct experiments for the evaluation of new or existing products. You will organize, analyze and present data relevant to performance and stability. You may participate in writing or revising SOPs and reports. You will also interact with QC, Manufacturing and Technical Service groups. Qualifications include a BA/BS degree in Chemistry, Biochemistry or a related scientific discipline with 1-5 years of industrial laboratory experience or a recent MS Degree in Chemistry or Biochemistry. You should be proficient in MS Excel, Word and Powerpoint. Previous formulations experience is a plus. How to Apply: Resumes must be sent via e-mail and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other openings, please visit our website: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 338 views

Analytical Chemist - Methods Development

2008-02-22T18:23:46Z

The selected candidate will be primarily responsible for the method development and validation testing of finished products and raw materials. You will perform a variety of analytical chemistry processes such as potency assay, content uniformity and impurities testing by HPLC under instructions. You will also be involved in the development of stability indicating HPLC methods, validation of HPLC methods, support ANDA using the following techniques GC, IR, UV, TLC and/or other wet chemistry techniques. You will follow work instructions under GMP guidelines and perform other tasks as needed in the R&D lab such as stability and in-process sample testing. Qualifications include a minimum of a BS degree in Chemistry or closely related with one year experience, or an MS degree, in a science related field with an emphasis in Chemistry preferred. Other fields such as Biology majors with equivalent chemistry background may also qualify. You must have strong mathematical skills and a knowledge and commensurate experience in wet chemistry techniques such as: HPLC, GC, UV, IR, TLC and other instrumental techniques preferred. Knowledge of FDA guidelines, USP & GMP procedures are preferred. How to Apply: Resumes must be sent via e-mail and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other openings, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Hayward / Castro Valley - 383 views

Senior Scientist - Immunodiagnostics

2008-01-08T19:35:14Z

The selected candidate will join the Clinical Diagnostics group and will be responsible for initiating and investigating scientific concepts related to the fulfillment of company long term goals. This position involves review and interpretation of scientific literature, laboratory investigations, project planning and interaction with other departments as needed to support company goals. Working independently, you will develop, design and perform experimental strategies and procedures for projects; conduct, direct and troubleshoot potentially highly complex technical experiments. You will also evaluate ideas which can lead to new or improved products or processes. Qualifications include a Ph.D. in a scientific discipline or a Masters degree with a minimum of 3 years of R&D experience. You must be able to effectively communicate and interact with others and do hands on work in the laboratory. Position requires knowledge and skill in operating automated clinical chemistry analyzers. Candidate will have demonstrated success in technical proficiency, scientific creativity and independent thought. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com to learn more about this position or to preview other openings, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 496 views

Technical Support Representative

2008-01-08T19:28:03Z

The selected candidate will provide customers and end users with product and technical support. You will respond to customer inquiries on the telephone, through on-line networks or by mail or fax. Willingness to return customer calls after office hours rotating with other Tech Support Reps. Communicates with customers to help them understand how to use the product properly. Handles customer problems that appear to arise from the use of the product. Handles requests for replacing defective products. Completes, maintains and processes pertinent paperwork and records. Provides periodic reports to management including product compilations, suggestions and trend analyses. Maintains a current source of reference material, articles, and technical manuals as required to provide current information. Reviews available technical literature to maintain an awareness of current methods and systems. Performs services for departments, customers and OEM partners. Makes recommendations to, negotiates with and influences actions of other departments, customers and OEM partners. Qualifications include a BA/BS degree in Chemistry, Medical Technology or Immunology with 2-4 years related experience or equivalent combination of education and experience. Excellent written and verbal communication skills are required. Working knowledge of Windows based spreadsheets, word processors and database management software. Familiarity with scientific and clinical laboratory terminology and testing. Ability to understand basic chemistry and chemical reactions. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this position or to preview other openings, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 360 views

Planner/Buyer

2008-01-08T19:24:53Z

The selected candidate will be responsible for planning all aspects of production using a MRPII Database. Initiate work orders and maintain accurate database. Includes interaction with other departments to ensure that company objectives are met for business revenues and customer satisfaction. Run meetings to update management. Work on complex analysis for determination of situations to ensure most cost effective means of manufacturing. Involved with the PCO, change process. Maintains the MRP and production plan for established products and new product transfers. Establishes priorities for specific customer orders. Provides regular and timely production reports to management. Monitors production plans/forecasts and recommends changes to management. Interfaces with Department Supervisors and Marketing Managers to coordinate and prioritize product availability to support customer service efforts. Oversees the material planning aspects of new product launches, packaging changes and product phase-outs. Responsible for ISO and QSR compliance and improvement initiatives within reporting department. Responsible for analysis and assistance with the process of change, PCO. Assist in fixing or creating BOMS. Also responsible for reconciling work order variances. Acts independently to determine methods and procedures on new assignments. Qualifications include a BA/BS degree in one of the Life Sciences or in Business and a minimum of 5 years experience in medical device industry of which at least 3 are in production planning & inventory control. Cost Accounting/Finance courses helpful. APICS CPIM, CIRM or CFPIM preferred. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this opening or to preview other positions, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 417 views

Research and Development Scientist - Immunohistochemistry

2008-01-08T19:19:11Z

The selected candidate will design, develop, and perform experimental strategies and procedures for designated projects. Routinely evaluates product candidates, such as antibodies, detection kits and other reagents and provides weekly progress reports to Lab Manager. Maintains good laboratory records of experimental design and data. Manages daily work flow in alignment with the department and company goals and timelines. Conducts and troubleshoots complex technical experiments. Works independently to determine methods and procedures on new assignments. Evaluates ideas for applications to existing projects, and concepts that can lead to new or improved products or processes. Assures compliance with GMP, QSRs, ISO and IVD regulations in the performance of department responsibilities. Maintains Design History Files and conducts design reviews. Designs and executes verification plans for new products. Participates in the validation of new products. Supports product launch team as required. Trains and provides technical guidance/leadership to research associates. Qualifications include an MS degree with six or more years of relevant R&D experience or PhD with four years of relevant R&D experience with an emphasis in biology, biochemistry or a related field. Must be able to do hands-on work in the laboratory, including immunohistochemistry and other molecular biology techniques. Requires knowledge and skill in operating automated immunohistochemistry slide staining systems, and knowledge of IHC reagent technology. Demonstrated success in technical proficiency, scientific creativity, and independent thought. Ability to meet critical product launch deadlines. Proven skills in interpretation of scientific literature and interaction with co-workers and other departments. Ability to multi-task and excellent organizational skills required. Must be able to effectively communicate and interact with others. Will train and provide technical guidance/leadership to lower level personnel. Provides input to the performance evaluations of co-workers and research associates. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this opening or to preview other positions, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 463 views

Project Marketing Specialist

2008-01-08T19:12:40Z

The selected candidate will support marketing activities for different product lines including OEM support, new product launch activities, tradeshow planning and preparation, new and revised marketing materials and advertisements. You will support activities for new product launches with tools, training materials and literature revisions, direct mailing campaigns, advertising and newsletters. You will assist in activities related to OEM products and projects including the set up of paperwork and documentation needed to add products to the different business systems and tradeshow calendar maintenance. You will collaborate with corporate and/or business unit tradeshow planning and establish the activities and paperwork involved in the process. You will maintain department documentation, rosters and maps and perform direct mailing projects and literature fulfillment requests. Qualifications include a BA in Marketing or closely related with 1-3 years of previous industry experience. Prior knowledge and/or experience in biomedical areas is preferred but not required. You should exhibit excellent communication and organizational skills. Prior project management experience is a plus. You must also be proficient in MS Word, Excel and PowerPoint. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To learn more about this opening or to preview other positions, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 417 views

Analytical Chemist - Methods Development

2008-01-08T19:09:13Z

The selected candidate will be primarily responsible for the method development and validation testing of finished products and raw materials. You will perform a variety of analytical chemistry processes such as potency assay, content uniformity and impurities testing by HPLC under instructions. You will also be involved in the development of stability indicating HPLC methods, validation of HPLC methods, support ANDA using the following techniques GC, IR, UV, TLC and/or other wet chemistry techniques. You will follow work instructions under GMP guidelines and perform other tasks as needed in the R&D lab such as stability and in-process sample testing. Qualifications include a minimum of a BS degree in Chemistry or closely related with one year experience, or an MS degree, in a science related field with an emphasis in Chemistry preferred. Other fields such as Biology majors with equivalent chemistry background may also qualify. You must have strong mathematical skills and a knowledge and commensurate experience in wet chemistry techniques such as: HPLC, GC, UV, IR, TLC and other instrumental techniques preferred. Knowledge of FDA guidelines, USP & GMP procedures are preferred. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com For more information or to preview other openings, please visit our website at: http://genquestbio.com/careers.htm

Location: Hayward / Castro Valley - 424 views

Scientist/Senior Scientist

2007-12-04T23:48:28Z

The selected candidate will join the Clinical Diagnostics group and will be responsible for initiating and investigating scientific concepts related to the fulfillment of company long term goals. This position involves review and interpretation of scientific literature, laboratory investigations, project planning and interaction with other departments as needed to support company goals. Working independently, you will develop, design and perform experimental strategies and procedures for projects; conduct, direct and troubleshoot potentially highly complex technical experiments. You will also evaluate ideas which can lead to new or improved products or processes. Qualifications include a Ph.D. in Biochemistry or closely related with 1-2 years of previous experience or a Masters degree with a minimum of 3 years of R&D experience. You must be able to effectively communicate and interact with others and do hands on work in the laboratory. Position requires knowledge and skill in operating automated clinical chemistry analyzers. Candidate will have demonstrated success in technical proficiency, scientific creativity and independent thought. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com For more information or to preview other openings, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 414 views

Technical Support Representative

2007-12-03T23:52:26Z

The selected candidate will provide customers and end users with product and technical support. You will respond to customer inquiries on the telephone, through on-line networks or by mail or fax. Willingness to return customer calls after office hours rotating with other Tech Support Reps. Communicates with customers to help them understand how to use the product properly. Handles customer problems that appear to arise from the use of the product. Handles requests for replacing defective products. Completes, maintains and processes pertinent paperwork and records. Provides periodic reports to management including product compilations, suggestions and trend analyses. Maintains a current source of reference material, articles, and technical manuals as required to provide current information. Reviews available technical literature to maintain an awareness of current methods and systems. Performs services for departments, customers and OEM partners. Makes recommendations to, negotiates with and influences actions of other departments, customers and OEM partners. Qualifications include a BA/BS degree in Chemistry, Medical Technology or Immunology with 2-4 years related experience or equivalent combination of education and experience. Excellent written and verbal communication skills are required. Working knowledge of Windows based spreadsheets, word processors and database management software. Familiarity with scientific and clinical laboratory terminology and testing. Ability to understand basic chemistry and chemical reactions. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com For more information about this position or to view other openings, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 456 views

Quality Systems Associate

2007-12-03T23:49:13Z

The selected candidate will with Regulatory affairs to audit batch records and associated documents to ensure that all documentation and specification requirements are met. You will identify non-conformances and errors found during the batch record review process and trend batch record issues. This will encompass the batch record review of raw materials, in-process and finished goods materials and processes. Review batch record supporting documentation, worksheets, temperature logs/charts, equipment logs, equipment print outs, non-conformity reports, CAPA etc. to ensure documentation is completed accurately and completely. You will track, trend and review statistics and corrective actions resulting from batch record issues. Qualifications include a high school diploma or equivalent with 2-4 years of industry experience. You should have competent knowledge of GMP/QSR/GDP regulations. Previous experience working with batch records is a plus. You must be proficient in MS Word, Excel and PowerPoint. You should be detail oriented, have excellent oral and written communication skills and exhibit the ability to find and solve problems. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com For more information about this position or to view other openings, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 437 views

Marketing Project Specialist

2007-12-03T23:46:04Z

The selected candidate will support marketing activities for different product lines including OEM support, new product launch activities, tradeshow planning and preparation, new and revised marketing materials and advertisements. You will support activities for new product launches with tools, training materials and literature revisions, direct mailing campaigns, advertising and newsletters. You will assist in activities related to OEM products and projects including the set up of paperwork and documentation needed to add products to the different business systems and tradeshow calendar maintenance. You will collaborate with corporate and/or business unit tradeshow planning and establish the activities and paperwork involved in the process. You will maintain department documentation, rosters and maps and perform direct mailing projects and literature fulfillment requests. Qualifications include a BA in Marketing or closely related with 1-3 years of previous industry experience. Prior knowledge and/or experience in biomedical areas is preferred but not required. You should exhibit excellent communication and organizational skills. Prior project management experience is a plus. You must also be proficient in MS Word, Excel and PowerPoint. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com To view more information about joining the GenQuest team, please visit our website at: http://genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 449 views

Chemist - Monoclonal Antibodies

2007-11-15T19:32:50Z

The selected candidate will manufacture products and completes associated documentation. You will contribute to the transfer of new products into Manufacturing. You will work to produce and purify antibodies using cGMPs. Develops and maintains hybridoma cell lines. Performs associated procedures using mice and in-vitro equipment. Performs analytical and functional testing of antibodies. Maintains lot histories. Completes accurate transactions within timeline guidelines. Maintains and validates equipment as appropriate. Keeps dept supervisor and/or manager updated on all issues. Performs other job duties as required. Acts independently to determine methods and procedures on new assignments. Qualifications include a BS/BA in scientific discipline (Chemistry or Biochemistry preferred) with 0-3 years related experience and/or training. Basic lab skills and knowledge of safety precautions. Familiarity with Quality System Regulations. Experienced in working with potentially hazardous chemicals and human source materials is preferred. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com

Full Time -

Location: Fremont / Union City / Newark - 505 views

Technical Support Representative

2007-10-22T18:07:10Z

The selected candidate will provide customers and end users with product and technical support. Responds to customer inquiries on the telephone, through on-line networks or by mail or fax. Willingness to return customer calls after office hours rotating with other Tech Support Reps. Communicates with customers to help them understand how to use the product properly. Handles customer problems that appear to arise from the use of the product. Handles requests for replacing defective products. Completes, maintains and processes pertinent paperwork and records. Provides periodic reports to management including product compilations, suggestions and trend analyses. Maintains a current source of reference material, articles, and technical manuals as required to provide current information. Reviews available technical literature to maintain an awareness of current methods and systems. Performs services for departments, customers and OEM partners. Makes recommendations to, negotiates with and influences actions of other departments, customers and OEM partners. Does not supervise. Qualifications include a BA/BS degree in Chemistry, Medical Technologist or Immunology with 2-4 years related experience or equivalent combination of education and experience. Excellent written and verbal communication skills are required. Working knowledge of Windows based spreadsheets, word processors and database management software. Familiarity with scientific and clinical laboratory terminology and testing. Ability to understand basic chemistry and chemical reactions. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com For more information or to preview other openings, please visit our website at: http://genquestbio.com/careers.htm Key Words: Medical Technologist, Med Tech, Immunology, Clinical Chemistry

Full Time -

Location: Fremont / Union City / Newark - 489 views

Quality Control Chemist

2007-10-22T18:01:20Z

Using standard operating procedures and good manufacturing practices, you will be responsible for conducting routine and non-routine analysis of incoming raw materials, work-in-process materials and/or matched kits and filled bottle reagents. Perform initial troubleshooting of issues which arise during routine analysis. Document test results, problems and other relevant information under cGMPs. Perform simple revisions and updates to SOPs as necessary. Participate in interdepartmental meetings. Perform other responsibilities to support the needs of the department as assigned by Supervisor. Qualifications include a BA/BS in Biochemistry, Chemistry or closely related with 0-2 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry. Strong laboratory skills including pipetting, safety, and hazardous chemical handling. Understanding of cGMP and how it applies to the work environment is preferred. High level of reading comprehension skills. Ability to follow written and verbal directions with a high level of accuracy. Must be able to write clear and understandable documentation. Manual dexterity, must be able to lift/move up to 20 pounds. Intermediate word processing and spreadsheet software skills. Ability to manage multiple tasks simultaneously. Ability to perform simple data analysis and to summarize results. Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts. How to Apply: Resumes must be sent via E-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com For more information or to preview other openings, please visit our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 497 views

Production Polymer Scientist

2007-10-22T17:58:09Z

The selected candidate will employ polymer synthesis technologies to produce spherical particles of desired size ranges. Use size purification and separation techniques to make spherical materials manufactured to meet written specifications. You will carry out production duties as defined by management. This requires completing lab notebook, batch records and other required paperwork completely and accurately. Perform quality evaluations of product and raw materials analysis to ensure particles meet written specifications. Follow written and oral instructions and procedures to complete assignments. Update and recommend changes to existing procedures as required. Qualifications include a minimum BA/BS in Bioscience or Chemistry with 1-4 years experience in a laboratory. Experience in particle/polymer science is not required but is a plus. Must have good math and oral and written communication skills. The use of computers is essential, must be proficient in MS Word and MS Excel. Must have some experience using a microscope. Good attention to detail and careful work habits are required. Other necessary required skills: Accurate weighing and pipetting, reactor setup/breakdown and safe chemical handling skills, analytical equipment, filtration, water bath, pH meter, conductivity meter, buret etc. How to Apply: Resume must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com For more information or to preview other openings, please visit our website: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 424 views

Quality Control Chemist

2007-10-12T22:55:55Z

Using standard operating procedures and good manufacturing practices, you will be responsible for conducting routine and non-routine analysis of incoming raw materials, work-in-process materials and/or matched kits and filled bottle reagents. Perform initial troubleshooting of issues which arise during routine analysis. Document test results, problems and other relevant information under cGMPs. Perform simple revisions and updates to SOPs as necessary. Participate in interdepartmental meetings. Perform other responsibilities to support the needs of the department as assigned by Supervisor. Qualifications include a BA/BS in Biochemistry, Chemistry or closely related with 0-2 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry. Strong laboratory skills including pipetting, safety, and hazardous chemical handling. Understanding of cGMP and how it applies to the work environment is preferred. High level of reading comprehension skills. Ability to follow written and verbal directions with a high level of accuracy. Must be able to write clear and understandable documentation. Manual dexterity, must be able to lift/move up to 20 pounds. Intermediate word processing and spreadsheet software skills. Ability to manage multiple tasks simultaneously. Ability to perform simple data analysis and to summarize results. Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com You may also preview other openings by visiting our website at: http://www.genquestbio.com/careers.htm

Full Time -

Location: Fremont / Union City / Newark - 21 views

Research Associate - Biochemistry

2007-09-06T23:14:34Z

The selected candidate will characterize novel enzymes involved in the etiology or pathology of diabetes and contribute to efforts to prepare these enzymes for HTS for the purpose of identifying novel therapeutics. Required skills include purification and characterization of enzymes from native sources and recombinant systems and analysis of substrate specificity, kinetic parameters and inhibitor profiles. Qualifications include a BS/MS degree in Biochemistry or closely related with at least two years of biochemical laboratory experience. Additional experience in HTS and robotics is a plus. The ideal candidate will have two or more years of laboratory experience in biochemistry, protein chemistry, enzymology and assay development. This position requires the safe handling of biohazard materials, hazardous materials and radioactive materials. How to Apply: Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: hr@genquestbio.com

Full Time -

Location: Hayward / Castro Valley - 80 views