3 Science jobs

A biotech manufacturing company in Sunnyvale, CA is looking for an Associate Scientist to work in the  Biotechnology group and is primarily a bench level job focusing on real time PCR and RT-PCR assay and product development in an FDA-QSR and ISO9001 compliant organization. The ideal candidate will have experience in general molecular biology methods.  In addition to technical qualifications, the ideal candidate will be highly goal-oriented and be able to respond to shifting demands and priorities and possess excellent oral and written communication skills. The ability to work in a cross-functional team-based environment is a requirement. Responsibilities: Optimize sample preparation, real time PCR and RT-PCR assays for the GeneXpert platform based on design input requirements. Help develop strategies for development of complex in vitro diagnostic tests. Maintain detailed experimental records. Apply analytical problem solving skills to reagent and system integration issues to identify critical performance factors. Present data at technical meetings. Provide input to the project schedule as required.

A biotech manufacturing company in Sunnyvale, CA is looking a Scientist to be a member of the company’s R&D organization.  The position will be an integral part of a team completing the design verification phase of a real-time PCR based CE-IVD product. The Scientist will perform bench level work focusing on design input requirements for CE-IVD product development in an FDA-QSR and ISO9001 compliant organization. Responsibilities: This will be primarily a hands-on, bench level position with key responsibilities in the area of completing analytical studies required for design verification of a real time nested PCR assay on the GeneXpert platform.  Involved in all aspects of assay development prior to validation phase which include: creating and validating test methods, SOP writing for manufacturing processes, data analysis and report writing. Maintenance of detailed experimental records is a must.

A biotech manufacturing company in Sunnyvale, CA is looking for a Control Material Analyst to perform qualification and manufacturing of template materials used in internal product testing and raw material for product build according to established procedures. This position will be working in operations facility to support control material production as well as control material stability program activities in accordance to GMP standards and FDA/ISO regulations. The successful candidate will have working knowledge of laboratory procedures, techniques, and methodologies, especially in handling bacterial cells, nucleic acid, viruses, etc.  RESPONSIBILITIES: Perform reference control material qualification/production Perform qualification/production of template material work order Aliquoting and labeling of template/control reference materials Report non-conformance material (initial observation of non-conformance) Participate in test method validation activities Revise and update minor changes to testing procedures, work instructions, and worksheet for correction or  process improvement Assist in batch record review Evaluate/Maintain proper control material usage rate and inventory to support operation testing needs Assist in stability testing or activities as needed Assist/Support in equipment maintenance/calibration activities if needed Perform other duties as assigned or requested.