The Biologics Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept. We have an exciting opportunity available for an Associate Scientist II to join our team at our Bay Area site in South San Francisco, CA. This is a lab-based position and requires fulltime on-site presence. Successful candidates will thrive in a collaborative lab environment.
Key responsibilities include:
- Own & support stability / in-use / process studies: work within the process operations team to fill development drug product batches for GLP toxicology studies, reference standard fills, and representative drug product batches. Develop skills to plan and execute screening, in-use, and formulation stability studies to support formulation and process development for clinical trials.
- Perform analytical assays & support troubleshooting: conduct analytical assays to evaluate protein and excipients stability (i.e. HPLC/UPLC, SEC, CEX, CE‑SDS, icIEF, UV-Vis, CD, Karl Fischer titration, HIAC, MFI). Generate high-quality data to support selection of formulation composition, development of dose administration guidance, and drug product manufacturing instructions. Develop the skills to independently troubleshoot assays and instruments to ensure consistent quality data output.
- Analyze & communicate results: analyze study results, organize and document the results in an electronic lab notebook (ELN), and effectively communicate updates, troubleshooting, and results to the team. Interpret results and draw conclusions from multistage experiments with support from study owners and project leads. Communicate aberrant data and lab issues to management to gain input and alignment on solution.
- Write technical reports and communicate technical updates: Author technical reports to support regulatory filings and present the study results and findings to the team
- Collaboration: Collaborate closely with highly matrixed team members to support pipeline programs and participate in project teams as a study owner