Catalent
Principal Scientist, Process Development – Downstream
Overview
Catalent is seeking a Principal Scientist, Process Development – Downstream to support the early phase and technical transfer processes for biologics manufacturing.
About Catalent
Catalent's Madison, Wisconsin facility is a state-of-the-art biologics development and manufacturing site supporting customers from research through early- and mid-stage clinical production.
Requirements & Eligibility
- Ph.D. in Biotechnology, Biochemical Engineering, Chemical Engineering, Biology, or a related scientific discipline with a minimum of 8 years of relevant industry experience; master's degree with a minimum of 12 years of experience; or bachelor's degr
- Demonstrated expertise in development and commercialization of mAbs, multispecifics, recombinant proteins, or other complex biologic therapeutics.
- Strong expertise in chromatography, filtration, UF/DF, viral filtration, and cell removal technologies.
- Proven experience leading technical programs and serving as a client-facing scientific representative.
- Demonstrated knowledge of cGMP environments, technology transfer, process characterization, and scale-up.
Key Responsibilities
- Serve as the scientific lead for downstream process development programs supporting monoclonal antibodies (mAbs), multispecific antibodies, and recombinant protein therapeutics.
- Guide the design, development, optimization, and characterization of downstream processes, including chromatography, ultrafiltration/diafiltration (UF/DF), viral filtration, clarification, and cell removal methodologies.
- Act as the primary technical contact for client development projects, leading meetings, communicating project status, and providing scientific rationale.
- Lead technology transfer activities, scale-up strategies, process characterization studies, and viral clearance programs.
- Collaborate with Process Development, MS&T, Manufacturing, Quality, and Analytical teams to drive project execution and troubleshoot technical challenges.
- Author, review, and approve technical documents including protocols, reports, SOPs, batch records, and client-facing deliverables.
- Evaluate emerging technologies, identify opportunities for process enhancement, and contribute to the advancement of scientific capabilities.
- Mentor scientists and technical staff, providing coaching, guidance, and knowledge-sharing to support team growth and development.
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