R&D Manager - Point-Of-Care Lateral Flow Diagnostics

Affimedix, Inc., a fast-growing Health & Wellness Diagnostic company in Silicon Valley, focuses on R&D, product design, development, manufacturing, and marketing of its proprietary Point-Of-Care Diagnostics. Affimedix is redefining Point-Of-Care Diagnostics for small molecule biomarkers using its game-changing Immuno-Sandwich Test technology. We are seeking a dedicated and innovative R&D Manager to lead our efforts in developing next-generation Point-Of-Care Lateral Flow Diagnostics.

Responsibilities:

• Contribute to building a novel technology that can shape the next generation of Wellness Diagnostics and at-home self-testing.
• Collaborate effectively with team members on new high-sensitivity rapid immunoassays projects, from conception to validation.
• Act as a technical leader for the state-of-the-art Rapid Lateral Flow Assay development team and mentor associates through assay design, feasibility study, optimization, validation and product development.
• Independently design experiments with an exceptional variable control for lateral flow assay development and optimization.
• Find creative and innovative ways to solve R&D challenges.
• Coordinate technical transfer of new assays and procedures for scaling up with Production department.
• Run experiments, record and analyze data, interpret and present results to the Management team.
• Conduct and oversee thorough statistical data analyses.
• Prepare comprehensive documentation, including data summaries, reports, and protocols required by FDA, IVDR and ISO regulations.
• Foster a professional, collaborative, and communicative workplace culture.

Qualifications:

• BS or MSc in Immunology, Biotechnology, Biochemistry, or a related Life Sciences field. 5+ years of proven track record in Lateral Flow Assay (LFA) development (other keywords include Lateral Flow Immunoassays (LFIA), Point-Of-Care Diagnostics (POCD), rapid diagnostic tests).
• Successfully brought Point-Of-Care Lateral Flow Diagnostics through key points in their life cycles (conception, verification, manufacturing, clinical trials, and global commercialization, etc.)
• Hands-on experience in fluorescence based Rapid lateral flow assays.
• An independent scientist who thinks critically and creatively and enjoys collaborating and sharing knowledge and ideas.
• Proven problem-solving skills.
• Exceptional data management, laboratory organization, and documentation skills, including experimental design, report writing, and protocol (SOP) development.
• Outstanding communication abilities, both verbal and written, with proficiency in presentation and computer skills.

Compensation:

Highly competitive package commensurate with experience.