Senior Scientist I - Bio CMC Purification Process Development

AbbVie•South San Francisco, CA

4d•$96,500 - $183,500•Onsite

About The Position

The Senior Scientist I is a member of AbbVie’s Biologics CMC Development team in the Bay Area, within the CMC Purification Development group. The team works across phases of CMC development, focusing on complex biologic therapies, including multispecifics and novel modalities, for clinical studies and eventual licensure. This is an onsite, lab-based role requiring work in a fast-paced, collaborative environment with daily face-to-face cross-functional interactions. The role applies downstream process-development expertise to design robust, phase-appropriate drug substance purification processes for GMP production, clinical studies, and licensure. The scientist owns purification deliverables for assigned programs, helps define drug substance development strategy as a functional lead on cross-functional CMC teams, and communicates data-driven recommendations, risks, and tradeoffs to stakeholders.

Requirements

Bachelor’s degree or equivalent education and typically 10+ years of experience; master’s degree or equivalent education and typically 8+ years of experience; or PhD and 0+ years with relevant postdoctoral or industry experience. Education should be 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.
Ability to work independently, plan and execute work, and prioritize tasks to meet deadlines in a fast-paced environment.
Depth of scientific knowledge in protein biochemistry, separation science, and/or bioprocess engineering, with ability to evaluate literature and apply findings to hypothesis-driven experimental design, data interpretation, and technical decision-making.
Ability to organize, analyze, visualize, and interpret complex process and analytical data using tools such as JMP, Python, R, or comparable software.
Forward-thinking approach and ability to lead and contribute to scientific and technical discussions and innovation.
Ability to independently learn, understand, and execute novel, advanced scientific techniques.
Excellent attention to detail and ability to maintain detailed written records.
Proven record of authoring publications, technical reports, regulatory documents, and/or presentations.
Strong verbal, written, and scientific data-presentation skills.
Ability to work collaboratively within and outside the group.

Nice To Haves

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 identifying critical quality attributes and process parameters.
Experience in mechanistic modeling of downstream purification unit operations, such as GoSilico, CADET, gPROMS, or similar frameworks, including chromatography and/or membrane separations.
Experience programming liquid-handling robots such as Tecan or Hamilton systems and automated chromatography platforms such as ÄKTA for high-throughput screening and purification studies.
Proficiency writing methods and operating ÄKTA chromatographic instruments such as ÄKTA Avant, ÄKTA Pure, ÄKTA Pilot, or ÄKTA Ready, or similar.
Strong understanding of statistical analysis, such as standard deviation and analysis of variance.
Familiarity with design-of-experiment software such as JMP.
Strong understanding of analytical techniques such as SEC, RP, SDS, icIEF, mass spectroscopy, and ELISA.
Previous regulatory filing experience, such as 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, such as GMP and ICH Guidelines.

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 aligned with the group’s strategy.
Review scientific literature, regulatory guidance, patents, and industry trends, and translate relevant advances into program strategy, experimental design, and platform development.
Pursue project-relevant leads aligned with the group’s strategy.
Write technical publications, reports, presentations, and regulatory filings, including publishing in peer-reviewed journals and presenting at scientific conferences.
Work efficiently and collaboratively across functions to meet project deliverables and timelines.
Follow corporate standards for conduct, safety, appropriate handling of materials, and GxP compliance where applicable.
Mentor and train junior scientists.