R&D Lab Scientist (MDR&DDJK) San Jose, California
A biotech company in the area is hiring a highly motivated Research Scientist.
This position offers an excellent compensation and benefits package; apply now!
Research Scientist Responsibilities:
- Work with lead scientist and product manager to research, develop and improve POC medical diagnostic products
- Participate in product development including feasibility, verification and validation, and manufacturing transfer to ensure that products are in compliance with CFDA, FDA and EU regulatory requirements and standards for clinical in vitro diagnostics applications.
- Conduct experiments to verify and validate device performance, ensuring that it meets or exceeds claims of product specifications and regulatory requirements.
- Analyze, summarize, and report data generated from experiments, draw conclusion from experimental results and suggest follow-up actions based on prior experimental findings.
- Assist in transfer from product development to manufacturing, providing detailed and complete technical information and documents related to the transfer process.
- Work closely with QC Department in providing Design Control Documents by following historic documents and resolving issues involving parts/products quality and regulatory/audit requirements.
- Provide technical support to product marketing and sales
- Coordinate with other researchers and professionals in support of internal and external audits.
- Perform other assignments, duties and assume additional responsibilities as required.
Research Scientist Requirements:
- PhD in Biochemistry or related field
- Lab experience with antibody, biosensors, microfluidics or immunoassay preferred
- Experience in manufacturing management desired
- Strong written and verbal communication skills.
- Ability to learn new skills and work in a fast-paced, highly productive and changing environment; flexibility and quick adaptability to shifting priorities.
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 31 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.