Principal Scientist - Process Development, Downstream

Catalent Pharma Solutions•Madison, WI

2d•Onsite

About The Position

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. 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.

Requirements

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.

Nice To Haves

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.
Strong business acumen and ability to build client relationships.

Responsibilities

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.
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.
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.
Lead technology transfer activities, scale-up strategies, process characterization studies, and viral clearance programs to support progression from development through cGMP manufacturing.
Collaborate with Process Development, MS&T, Manufacturing, Quality, and Analytical teams to drive project execution, troubleshoot technical challenges, and ensure successful project delivery.
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.
Evaluate emerging technologies, identify opportunities for process enhancement, and contribute to the advancement of scientific capabilities, service offerings, and best practices within the organization.
Mentor scientists and technical staff, providing coaching, guidance, and knowledge-sharing to support team growth and development.
Other responsibilities as needed.