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, multispecitics, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept.
We have an exciting opportunity for a Scientist I/II to join our team at our Bay Area site in South San Francisco, CA. This role is an onsite role in a lab-based function and will focus on driving drug product development through formulation, process and in-use and will be the HPLC/UPLC technical lead and subject matter expert. This position is ideal for a scientist with experience in biologics formulation and characterization who is passionate about chromatography and eager to support the team as to ensure utility and maintenance of HPLC/UPLC instruments. To be successful, candidates must thrive in a highly collaborative laboratory environment with daily face-to-face interactions across multiple scientific disciplines.
KEY RESPONSIBILITIES INCLUDE:
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 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 and training materials, and serve as a technical resource and scientific consultant on HPLC-related matters.
May provide guidance for HPLC/UPLC method adjustments to enable accelerated characterization of new molecules.
Scientific Contribution & Communication
Independently analyze, interpret, and document experimental data in electronic lab notebooks (ELN) with clarity and completeness.
Present scientific findings to project teams, management, and cross-functional stakeholders with confidence and scientific rigor.
Author technical reports, SOPs and development summaries and contribute to regulatory documents, scientific publications, and patent applications as needed.
Stay current with emerging trends and innovations in formulation science, analytical chemistry, and HPLC/UPLC technology; proactively apply learnings to internal programs.