Senior Scientist I - Bio CMC Purification Process Development

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
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:
Hands-on experience developing purification processes for monoclonal antibodies, multispecifics, antibody-drug conjugates, or other antibody-like molecules at laboratory, pilot, and/or GMP scale
Experience developing scalable purification processes and applying quality-by-design principles, including identification of critical quality attributes and process parameters, is required
Proven experience in mechanistic modeling of downstream purification unit operations (e.g. GoSilico, CADET, gPROMS or similar framework) including chromatography separations and/or membrane separations
Proven experience in programming liquid-handling robots (like Tecan or Hamilton systems) and automated chromatography platforms (like ÄKTA) to execute high-throughput screening and purification studies.
Proficient in writing methods and operating AKTA chromatographic instruments (such as AKTA Avant, AKTA Pure, AKTA Pilot, AKTA Ready or similar)
Has a strong understanding of statistical analysis, such as standard deviation and analysis of variance
Familiarity with design of experiment (DoE) software, such as JMP
Has a strong understanding of analytical techniques, such as SEC, RP, SDS, icIEF, mass spectroscopy, and ELISA
Has previous regulatory filing experience (e.g. IND/IMPD)
Experience authoring process-development reports, technology-transfer protocols, process characterization summaries, and CMC sections supporting regulatory submissions
Demonstrated scientific aptitude through authorship of peer-reviewed publications
Familiarity with pharmaceutical regulations and guidelines (e.g. GMP and ICH Guidelines)

Employment type
Full-time

Work arrangement
No