Principal Scientist - Process Development, Downstream
Catalent
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 19 days ago
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