Scientist II, Biologics Drug Product Development

Job description

Job Description
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.

Qualifications
Education

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related discipline with typically 4-5 years (Scientist I) or 7+ years (Scientist II) of relevant industry experience

• Master’s degree in a related discipline with typically 2 years (Scientist I) or 5+ years (Scientist II) of relevant industry experience

Required Experience & Skills

• Demonstrated hands-on experience in biologics drug product development, including formulation development, characterization, and stability assessment.

• Strong practical understanding of protein degradation pathways and analytical characterization approaches used to assess biologic product quality.

• Broad and deep hands-on expertise with HPLC/UPLC across multiple modalities (e.g. RP, SEC, IEC, HIC, etc.) with a proven track record as an SME, including method development and troubleshooting capabilities

• Hands-on experience with analytical techniques used for protein characterization and stability testing (e.g., SEC, RP-HPLC, CE-SDS, icIEF, HIAC, MFI, DLS, SoloVPE or equivalent).

• Experience with in-use stability and/or clinical compatibility studies for biologic drug products preferred.

• Proficiency in scientific data analysis and statistical

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