Associate Scientist II, Biologics Drug Product Development

Role Summary

The Associate Scientist II will join AbbVie's Biologics Drug Product Development group at the Bay Area site in South San Francisco, CA. This is a lab-based position requiring full-time on-site presence and focusing on developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics from preclinical development through clinical proof of concept. The role emphasizes collaborative work within a matrixed team to support pipeline programs.

Responsibilities

• 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

Qualifications

• Strong technical background encompassing protein chemistry and protein handling.
• Hands-on experience with running and troubleshooting analytical techniques used for protein characterization and stability testing such as SEC, CEX, iCIEF, CE-SDS, HIAC, and MFI.
• Ability to work in cross-matrixed team supporting multiple projects and participate in project-focused teams.
• Technical ability to execute and troubleshoot experiments through rational and critical thinking. Must be highly organized and detail oriented.
• Eagerness to learn and apply new scientific techniques.
• Prior experience in protein formulation development, process development, drug delivery, or analytical functions is highly preferred.
• Prior experience utilizing automated liquid handlers and/or executing high-throughput screening workflows is highly preferred.

Education

• Degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or equivalent; Bachelor's Degree with 3+ years’ experience or Master’s Degree (no additional experience).

Skills

• Excellent verbal and written communication skills.
• Strong collaborative skills for working effectively within the team.
• Strong technical troubleshooting and problem-solving abilities.
• Detail-oriented, highly organized, and able to manage multiple priorities in a matrixed environment.