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About the Role
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.
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
Requirements
- 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.
- 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 independently design, execute, use and reference literature publications, and interpret laboratory experiments to answer scientific questions.
Location
- Bay Area
- South San Francisco
Work Type
- Onsite
- Lab-based
Experience Level
- 12+ years of experience with Bachelor's Degree
- 10+ years of experience with Master's Degree
- 4+ years of experience with PhD
Education Level
- Bachelor's Degree
- Master's Degree
- PhD
Salary/Compensations
- USD 109500 - USD 208500 - yearly
Benefits
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k)
- Eligible to participate in long-term incentive programs
About the Company
- 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.
Equal Opportunity
- AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
- Equal Opportunity Employer/Veterans/Disabled.
- US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html