Principal Scientist, Biologics Process Development - Downstream Purification
About The Position
Catalent is seeking a Principal Scientist to support late-stage biologics process development, technology transfer, and commercialization for therapeutic proteins and antibodies. This highly visible, client-facing role supports programs involving monoclonal antibodies, bispecific antibodies, and recombinant proteins. The position is approximately 25% hands-on laboratory work, with most time focused on technical leadership, program management, and guiding downstream purification development activities such as chromatography, UF/DF, filtration, viral clearance, and cell removal. The successful candidate will provide scientific leadership for purification process development, scale-up, characterization, technology transfer, and manufacturing readiness. The role serves as a primary technical contact for clients and collaborates with cross-functional teams to advance programs from development through cGMP manufacturing and commercialization. It also includes technical documentation, evaluation of emerging technologies, continuous improvement, and mentorship of scientists and technical staff. The position is 100% onsite at Catalent's Madison, Wisconsin facility and follows a Monday–Friday, first-shift schedule.
Requirements
- Ph.D. in Biotechnology, Biochemical Engineering, Chemical Engineering, Biology, or a related scientific discipline with at least 8 years of relevant industry experience; or a master's degree with at least 12 years of experience; or a bachelor's degree with at least 15 years of experience.
- Industry experience developing, optimizing, scaling, and transferring downstream purification processes for monoclonal antibodies, bispecific antibodies, recombinant proteins, or other complex biologic therapeutics.
- Strong expertise in chromatography, filtration, UF/DF, viral filtration, viral clearance, and cell removal technologies.
- Experience supporting late-stage development programs, process characterization studies, technology transfer, and commercial manufacturing readiness.
- Experience working in a biopharmaceutical, biotechnology, pharmaceutical, or biologics CDMO environment.
- Experience leading technical programs and serving as a client-facing scientific representative.
- Knowledge of cGMP environments, scale-up activities, and manufacturing support.
- Excellent scientific communication, problem-solving, and project management skills.
Nice To Haves
- Experience in a biopharmaceutical, biotechnology, pharmaceutical, or CDMO environment supporting biologics manufacturing.
- Experience with industrial-scale purification processes for monoclonal antibodies, bispecific antibodies, and/or recombinant proteins.
- 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, process characterization, commercial manufacturing readiness, and lifecycle management.
- Strong business acumen and ability to build client relationships.
- Experience partnering closely with MS&T and manufacturing operations during technology transfer and commercialization.
Responsibilities
- Serve as scientific lead for downstream process development programs supporting monoclonal antibodies, bispecific antibodies, and recombinant protein therapeutics.
- Provide strategic direction, scientific consultation, and technical oversight across multiple client programs, focusing on purification process development, scale-up, technology transfer, and commercial readiness.
- Guide the design, development, optimization, and characterization of downstream purification processes, including chromatography, UF/DF, viral filtration, clarification, and cell removal.
- Act as the primary technical contact for client development projects; lead meetings, communicate project status, provide scientific rationale, and align technical execution with program objectives.
- Lead technology transfer, process characterization, scale-up strategies, validation readiness initiatives, and viral clearance programs supporting cGMP manufacturing and commercialization.
- Collaborate with Process Development, MS&T, Manufacturing, Quality, Regulatory, and Analytical teams to execute projects, troubleshoot technical challenges, and deliver projects successfully.
- Author, review, and approve technical documents, including protocols, reports, SOPs, batch records, and client-facing deliverables, ensuring compliance with Good Documentation Practices and regulatory expectations.
- Evaluate emerging technologies, identify process improvements, and contribute to scientific capabilities, service offerings, and organizational best practices.
- Mentor scientists and technical staff through coaching, guidance, and knowledge-sharing.
- Perform other responsibilities as needed.
Benefits
- 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 plus 8 holidays).
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
