Principal Scientist - Process Development, Downstream

Principal Scientist – Process Development, Downstream Catalent is seeking a Principal S cientist, Process Development – Downstream to support the early phase and technical transfer processes for biologics manufacturing . This is a highly visible, client-facing Process Development role supporting the advancement of biologics programs across a diverse portfolio of mAbs , multispecifics , and recombinant proteins. While approximately 25% hands-on laboratory based, the majority of the role focuses on technical leadership, program management, and guiding teams through downstream process development activities including chromatography, UF/DF, filtration, viral clearance, and cell removal processes. About Catalent Madison 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. Located at 726 Heartland Trail, the 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance manufacturing, and biopharmaceutical process development. The site is home to Catalent's proprietary GPEx ® and GPEx ® Lightning technologies, enabling the generation of high-producing mammalian cell lines for biologic therapies. With production capabilities ranging from 50L to 4,000L and a recent $45 million expansion, the Madison campus continues to play a critical role in Catalent's global biologics network while supporting Wisconsin's growing life sciences industry. Location: 100% Onsite at our facility in Madison, Wisconsin Shift: Monday – Friday, First Shift Key Responsibilities Technical Leadership & Scientific Strategy: Serve as the scientific lead for downstream process development programs supporting monoclonal antibodies ( mAbs ), multispecific antibodies, and recombinant protein therapeutics. Provide strategic direction, scientific consultation, and technical oversight across multiple client programs. Process Development Oversight: Guide the design, development, optimization, and characterization of downstream processes, including chromatography, ultrafiltration/diafiltration (UF/DF), viral filtration, clarification, and cell removal methodologies to enable successful clinical and commercial manufacturing. Client Partnership & Program Management: Act as the primary technical contact for client development projects, leading meetings, communicating project status, providing scientific rationale, and ensuring alignment between technical execution and program objectives . Technology Transfer & Commercial Readiness: Lead technology transfer activities, scale-up strategies, process characterization studies, and viral clearance programs to support progression from development through cGMP manufacturing. Cross-Functional Leadership: Collaborate with Process Development, MS&T, Manufacturing, Quality, and Analytical teams to drive project execution, troubleshoot technical challenges, and ensure successful project delivery. Technical Documentation & Review: Author, review, and approve technical documents including protocols, reports, SOPs, batch records, and client-facing deliverables while ensuring compliance with Good Documentation Practices (GDP) and regulatory expectations. Innovation & Continuous Improvement: Evaluate emerging technologies, identify opportunities for process enhancement, and contribute to the advancement of scientific capabilities, service offerings, and best practices within the organization. Mentorship & Scientific Development: Mentor scientists and technical staff, providing coaching, guidance, and knowledge-sharing to support team growth and development. Other responsibilities as needed. Required Qualifications 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 degree with a minimum of 15 years of experience. 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. Excellent scientific communication, problem-solving, and project management skills. Preferred Qualifications Experience in a biopharmaceutical, biotechnology, or CDMO environment. Track record of leading cross-functional teams and mentoring scientific staff. Experience supporting multiple client programs simultaneously. Expertise in viral clearance studies, late-stage process development, and commercial manufacturing readiness.