Senior Scientist 1, Bioassay Development, CMC Biologics, Analytical Research & Development

Job description

Senior Scientist 1, Bioassay Development, CMC Biologics, Analytical Research & Development, AbbVie Biotherapeutics Inc., South San Francisco, CA: Onsite (onsite 5 days per week). Key Responsibilities • Develop & optimize complex bioassays & target-binding potency assays critical for development of complex biotherapeutics. • Collaborate with analytical teams to elucidate structure/function & interact cross-functionally with teams from Discovery, Chemistry Manufacturing & Controls (CMC), QC, QA to support drug development activities & IND submissions. • Qualify/validate/transfer potency methods to external partners & author technical documents (e.g. test methods, protocols, & reports) to enable regulatory submissions). • Develop new techniques, explore new approaches & technologies, perform troubleshooting & optimization experiments, & present your work to various cross-functional teams. Education & Experience Must possess a MS degree in biology, biochemistry, cell/molecular biology, or a related field & 1 year of academic research experience or industry work as a development scientist. Of academic research experience &/or industry work experience required, must have 1 year: • developing binding potency assays (ELISA, TR-FRET, Octet, flow cytometry, other cell-based formats) to characterize & test protein therapeutics (monoclonal antibodies, ADCs, &/or other biologic modalities); • developing cell-based functional potency assays (cytotoxicity assays, reporter gene assays, proliferation assays, effector function activity assays (i.e. ADCC, CDC) to characterize & test protein therapeutics (monoclonal antibodies, ADCs, &/or other biologic modalities); • performing cell-based target binding potency assays, noncell-based target binding potency assays, &/or functional potency assays to characterize drug mechanism of action; • using GraphPad PRISM, PLA, Softmax Pro, or similar data analysis software; • optimizing & troubleshooting potency assays to improve performance &/or resolve performance issues; • working in a matrixed organization within a crossfunctional scientific environment within a (CMC) organization; & • authoring technical reports, drafting SOPs, writing CMC sections of regulatory filings, & giving scientific presentations to peers & management. Alternatively, would accept BS Degree in biology, biochemistry, cell/molecular biology, or a related field & 5 years academic research experience &/or industry work experience required as a development scientist. Of work experience required, must have 5 years of academic research experience &/or industry work experience in each of (i) (ii), (iii), (iv), (v), (vi) & (vii). Work experience may be gained concurrently. Will accept combination of education, training & work experience. AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .