Principal Scientist - Process Development, Downstream

Principal Scientist – Process Development, Downstream Catalent is seeking a Principal Scientist, 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

• 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.

• Ph.D. in Biotechnology, Biochemical…