Scientist II, Biologics Drug Product Development

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

About the role

The 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, multispecifics, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept. This role is an onsite role in a lab-based function at the Bay Area site in South San Francisco, CA. The scientist will focus on driving drug product development through formulation, process and in-use studies and will serve as the HPLC/UPLC technical lead and subject matter expert. The position requires experience in biologics formulation and characterization, passion for chromatography, and ability to support the team to ensure utility and maintenance of HPLC/UPLC instruments. Success depends on thriving in a highly collaborative laboratory environment with daily face-to-face interactions across multiple scientific disciplines.

Responsibilities

• Formulation & Biologics Drug Product Development: 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 team 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.
• HPLC/UPLC Subject Matter Expertise: Serve as the primary technical resource and owner for HPLC/UPLC systems within the Drug Product Development group and 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