Principal Scientist – Process Development, Downstream

Catalent is seeking a Principal Scientist, Process Development – Downstream to support theearly phase andtechnical transferprocesses 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.

Location: 100% Onsite at our facility in Madison, Wisconsin
Shift: Monday 6 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; master9s degree with a minimum of 12 years of experience; or bachelor9s 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.

• Strong business acumen and ability to build client relationships.

Why you should join Catalent

• Opportunity to play a key role in driving growth within a global CDMO leader.

• Competitive compensation package, including incentive opportunity.

• Day-one medical, dental, and vision coverage.

• 401(k) with company match.

• Tuition reimbursement and professional development opportunities.

• Generous paid time off and holiday schedule (152 hours + 8 holidays)

• Collaborative, mission-driven culture focused on improving patient outcomes worldwide.