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R&D Manager
4 months ago
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.
