The Biologics CMC Development team at AbbVie in the Bay Area has a long and rich history of biologics development. Located in a state-of-the-art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapies, such as multi-specifics, and novel modalities, to human clinical studies and eventual licensure. This role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel biologics and successfully filed two BLAs.
As a member of the CMC Purification Development group, you will apply strong downstream process-development expertise to design robust, phase-appropriate drug substance purification processes for GMP production, clinical studies, and eventual licensure. You will own purification deliverables for assigned programs, help define drug substance development strategy as a functional lead on cross-functional CMC teams, and communicate data-driven recommendations, risks, and tradeoffs to key stakeholders.
This position is an onsite role in a lab-based function. To be successful candidates must enjoy and thrive in a fast-paced and highly collaborative lab environment with daily face-to-face cross-functional interactions between scientists.
Responsibilities
- Develop, optimize, characterize, and scale up purification processes for monoclonal antibodies, multispecifics, antibody-like molecules, and other complex biologic candidates across early- and late-stage drug substance process development
- Lead technology transfer to internal or external GMP manufacturing sites; author transfer packages, support facility fit and readiness, and provide technical troubleshooting during clinical manufacturing
- Develop viral clearance strategy and oversee studies with contract laboratories, including protocol development, technical review, data interpretation, and report approval
- Optimize purification platforms and deepen process understanding through mechanistic modeling, statistical design of experiments, data analytics, and targeted wet-lab studies
- Conceive and evaluate novel, advanced bioprocess technologies that are in line with the group’s strategy
- Maintain current scientific knowledge by critically reviewing peer-reviewed literature, regulatory guidance, patents, and emerging industry trends, and translate relevant advances into program strategy, experimental design, and platform development
- Seize opportunities to pursue project relevant leads that are in line with the group’s strategy
- Write technical publications, reports, presentations, and regulatory filings including publishing research in peer-reviewed journals and presenting work at scientific conferences
- Work efficiently, collaboratively, and cross-functionally to meet project deliverables and timelines.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GxP compliance, where applicable
- Mentor and train junior scientists