Scientist II, Biologics Drug Product Development

About the role

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues and address future medical challenges across immunology, oncology, neuroscience, and its Allergan Aesthetics portfolio. The Drug Product Development group develops and characterizes drug product formulations and manufacturing processes for biologics (antibodies, multispecifics, ADCs, neurotoxins, novel formats) from preclinical through clinical proof of concept. This Scientist I/II position is based onsite at the Bay Area site in South San Francisco, CA, focusing on formulation development, HPLC/UPLC subject matter expertise, and scientific communication.

Responsibilities

• Independently lead and execute drug product development studies to support clinical studies, including formulation screening, in-use studies, and manufacturing process support.
• Generate robust scientific data and documentation to support IND/NDA/BLA regulatory submissions, CTD module documentation, and technical reports.
• Collaborate with cross‑functional partners including Analytical Development and Drug Substance teams to advance pipeline programs.
• Develop scientific understanding of formulation attributes and product quality characteristics through hands‑on laboratory experimentation and data interpretation.
• Contribute to continuous improvement of formulation strategies and drug product processes, applying scientific rigor and innovation.
• Serve as the primary technical resource and owner for HPLC/UPLC systems within the Drug Product Development group; implement a system to keep HPLC/UPLC instruments maintained, operational, and minimize downtime.
• Lead troubleshooting and root‑cause investigations for chromatographic instrumentation, methods, and data acquisition systems to maximize instrument uptime and laboratory productivity.
• Coordinate instrument maintenance, qualification activities, and vendor support while ensuring compliance with laboratory procedures and quality requirements.
• Act as an Empower software superuser by supporting users, troubleshooting data acquisition and processing issues, and promoting efficient data management practices using AbbVie data strategy tools.
• Develop and deliver HPLC training curricula, maintain SOPs