Associate Scientist II - Biologics Drug Product Development

About the role

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

Qualifications & Requirements

• Degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or equivalent
• Bachelor's degree and typically 3-5 years of experience or master's degree and typically 0-2 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.
• 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• 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.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.