R&D Scientist / Manager - Rapid Lateral Flow Diagnostics

R&D Scientist / Manager - Product Development for Lateral Flow Rapid Diagnostics
Affimedix, a fast growing Medical Device company in San Francisco bay of California, focuses on R & D, product design, development, manufacturing and marketing of its “Proprietary” Point-Of-Care Health Diagnostics globally.

Responsibilities:

• Conduct state-of-the-art Rapid Lateral Flow immunoassays development, including reagent screening, proof-of-concept, feasibility study, optimization, validation and final product development.
• Prepare technical SOPs as required for review and approval.
• Compile and analyze data; prepare reports and documentations.
• Prepare assay validation reports and other assay-related documentation as required by FDA and ISO regulations.
• Coordinate technical transfer of new assays and procedures for scaling up with Production department.

Qualifications:

• Minimum BS in Life Sciences or a related science field; Advanced degree with experience in diagnostic industry is Preferred.
• Minimum 5 years of relevant experience in diagnostic, lateral flow technologies.
• Demonstration of successful Rapid lateral flow product development.
• Hands-on experience in fluorescence based Rapid lateral flow assays is Preferred.
• Must have knowledge and or involvement in clinical trials.

Salary: DOE