Principal Scientist - Process Development, Downstream

Catalent · Madison, WI

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Role summary

Catalent seeks a Principal Scientist for downstream process development to lead biologics manufacturing programs from early phase through technical transfer. The role combines technical leadership with hands-on laboratory work, focusing on chromatography, purification, and filtration process optimization for monoclonal antibodies, multispecific antibodies, and recombinant proteins.

What they're looking for

Ph.D. in Biotechnology, Biochemical Engineering, Chemical Engineering, Biology, or related discipline
Minimum 8 years of relevant biopharmaceutical industry experience
Expertise in downstream bioprocess development including chromatography and ultrafiltration/diafiltration
Experience with viral clearance, filtration, and cell removal process development
Strong technical leadership and cross-functional collaboration capabilities
Knowledge of cGMP manufacturing, regulatory compliance, and Good Documentation Practices

What you'll be doing

Serve as scientific lead and primary technical contact for downstream process development programs across multiple client projects
Design, develop, and optimize downstream purification processes including chromatography, UF/DF, and viral filtration methodologies
Lead technology transfer activities and scale-up strategies to support progression from development to commercial manufacturing
Mentor scientific and technical staff; author and review technical documentation and regulatory submissions
Collaborate with cross-functional teams to troubleshoot challenges and ensure successful project delivery

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Date posted2 days ago

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