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.
- 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.
Bachelor's Degree in a Life Sciences discipline. At least 2 years of experience at a molecular diagnostics company, public health laboratory or similar institution.
Strong general science background in several disciplines and possess skills associated with CE-IVD product development.
Strong computer skills including proficiency with Microsoft Word and Excel, statistical software, and literature search technology required.
Excellent written and oral communication skills and proven interpersonal and team skills are required.
Capable of hands-on work while managing individual and team timelines successfully.
Ability to produce clear, understandable documentation.
Experience in the design and development of highly multiplexed real-time PCR assays, with a proven track record of interfacing between development, production, and quality systems during the development of CE-IVD or FDA approved IVD products.
Must be self-driven and flexible contributor who can allocate time and resources efficiently, effectively prioritize, and continually seek ways to improve individual and corporate efficiency.
Knowledge of cGMP, Design Control and the FDA approval process would be a plus. Experience with design of experiments methods and statistical analysis.
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.