Senior Scientist 1, Bioassay Development, CMC Biologics, Analytical Research & Development Full-time

Senior Scientist 1, Bioassay Development, CMC Biologics

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.

Job Location: 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.

Qualifications:

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:

1. 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);
2. 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);
3. performing cell-based target binding potency assays, noncell-based target binding potency assays, &/or functional potency assays to characterize drug mechanism of action;
4. using GraphPad PRISM, PLA, Softmax Pro, or similar data analysis software;
5. optimizing & troubleshooting potency assays to improve performance &/or resolve performance issues;
6. working in a matrixed organization within a crossfunctional scientific environment within a (CMC) organization; &
7. 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.

Salary Range: $143,067.06 – $162,000.00 per year.