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

AbbVie•South San Francisco, CA

1d•$143,067 - $162,000•Onsite

About The Position

AbbVie Biotherapeutics Inc. is seeking a Senior Scientist 1 for Bioassay Development within the CMC Biologics, Analytical Research & Development team in South San Francisco, CA. This is an onsite position requiring 5 days per week in the office. The role involves developing and optimizing complex bioassays and target-binding potency assays crucial for the development of complex biotherapeutics. The scientist will collaborate with analytical teams to understand structure/function relationships and work cross-functionally with teams from Discovery, Chemistry Manufacturing & Controls (CMC), QC, and QA to support drug development activities and IND submissions. Responsibilities also include qualifying, validating, and transferring potency methods to external partners, and authoring technical documents for regulatory submissions. The role encourages developing new techniques, exploring novel approaches and technologies, performing troubleshooting and optimization experiments, and presenting findings to various cross-functional teams.

Requirements

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.
1 year of 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).
1 year of 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).
1 year of performing cell-based target binding potency assays, noncell-based target binding potency assays, &/or functional potency assays to characterize drug mechanism of action.
1 year of using GraphPad PRISM, PLA, Softmax Pro, or similar data analysis software.
1 year of optimizing & troubleshooting potency assays to improve performance &/or resolve performance issues.
1 year of working in a matrixed organization within a crossfunctional scientific environment within a (CMC) organization.
1 year of authoring technical reports, drafting SOPs, writing CMC sections of regulatory filings, & giving scientific presentations to peers & management.
Alternatively, 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.
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.

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.