Scientist I/Associate Scientist II, Biologics Drug Product Development

AbbVie • South San Francisco, CA

3d • Onsite

About The Position

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 Scientist I or 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.

Requirements

• Degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or equivalent
• Bachelor’s Degree with 5 or more years’ experience or Master’s Degree with 2+ years of experience
• 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.
• Excellent verbal and written communication skills.
• Strong collaborative skills for working effectively within the team.

Nice To Haves

• 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.

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

Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level