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Form of workThe Bioassay Development group at AbbVie South San Francisco, CA is seeking a Scientist II to support the development and evaluation of newly discovered oncology and immunology drugs and existing clinical candidates. The selected candidate will join the Biologics Analytical Research and Development team, which has been involved in the development and IND submissions of 20 novel biologic drugs and the successful filing of two BLAs. In this lab-based role, you will have unique and diverse exposure to drug development activities, numerous cross-functional interactions, and opportunities to grow and develop in your scientific career.
Responsibilities:
Development and optimization of complex cell-based functional assays (bioassays) and target-binding potency assays critical for the development of therapeutic antibodies, antibody-drug conjugates (ADCs), multi-specific biologics, and novel/complex antibody variants.
Collaborate with Analytical Research and Development teams to elucidate structure/function molecular characterization and interact cross-functionally with teams from Discovery, CMC, QC, and more.
Perform potency testing and characterization to support drug development activities and IND submissions.
Qualify/validate/transfer potency methods to external partners and author technical documents (e.g. test methods, protocols, and reports) to enable regulatory submissions.
Develop new techniques, explore new approaches and technologies, perform troubleshooting and optimization experiments, and present your work to various cross-functional teams.
Requirements:
- Degree in biology, biochemistry, cell/molecular biology, or a related field with typically 7 years (BS) or 5 years (MS) of relevant industry experience
- Demonstrated experience with current binding potency assay approaches, such as ELISA, flow cytometry, and/or other binding potency assay platforms (i.e. TR-FRET, Octet, etc)
- Demonstrated experience with current cell-based assay methodologies, such as cytotoxicity assays, reporter gene assays, proliferation assays, primary cell-based assays, and/or effector function activity assays (i.e. ADCC, CDC, etc)
- Experience performing cell-based assays, mammalian cell culture, and/or target binding potency assays, preferably in a Bioassay Development group within a Chemistry Manufacturing and Controls (CMC) organization.
- Experience using PRISM, PLA, Softmax Pro, or similar data analysis software.
- Direct experience with biologics, monoclonal antibodies, and/or protein therapeutics is a plus.
- Direct experience with potency assay optimization and troubleshooting is a plus.
- Proven ability to work in a highly collaborative, cross-functional scientific environment.
- Strong verbal and written communication skills.
- Demonstrated abilities to quickly learn new skills, think independently, and work collaboratively in teams.
- The ideal candidate will be hard-working, self-motivated, detail-oriented, highly organized, and able to adapt quickly to changes.
