Senior Scientist I - Bio CMC Purification Process Development

Job Description

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

Qualifications

• Bachelor’s Degree or equivalent education and typically 10+ years of experience, Master’s Degree or equivalent education and typically 8+ years of experience, PhD and 0+ years with relevant postdoctoral or industry experience (Education in Chemical Engineering, Biochemistry, Chemistry, or a closely related field)
• Demonstrated understanding of downstream bioprocess unit operations, including affinity, ion-exchange, and hydrophobic-interaction chromatography; depth and virus filtration; tangential-flow filtration; and formulation or bulk drug substance handling
• Proven ability to work independently, effectively plan and execute work activities, and prioritize task completion to meet project deadlines in a fast-paced environment
• Demonstrated depth of scientific knowledge in protein biochemistry, separation science, and/or bioprocess engineering, with the ability to critically evaluate scientific literature and apply relevant findings to hypothesis-driven experimental design, data interpretation, and technical decision-making
• Able to organize, analyze, visualize, and interpret complex process and analytical data using tools such as JMP, Python, R, or comparable software
• Must be forward-thinking and be able to lead and contribute to scientific/technical discussions and innovation
• Able to independently learn, understand and execute novel, advanced scientific techniques
• Must have excellent attention to detail and ability to keep detailed written records
• Proven record of authoring publications, technical reports, regulatory documents, and/or presentations
• Has strong communication skills including verbal, written, and scientific data presentation
• Able to work collaboratively within and outside of the group
  
  Preferred:

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