Principal Scientist - Process Development, Downstream

Catalent; Madison (WI); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Day-one medical coverage

401(k) with match

Tuition reimbursement

Paid time off

Job summary

Catalent is seeking a Principal Scientist in Process Development – Downstream to lead upstream/downstream activities for biologics programs at our Madison site. The role blends scientific leadership with client-facing project management, overseeing downstream processes across mAbs, multispecifics, and proteins.

Responsibilities include guiding chromatography, UF/DF, filtration, and viral clearance while driving technology transfer and cGMP readiness.

Qualifications

• Ph.D. or advanced degree with extensive biologics development experience.
• Strong track record in downstream development of mAbs and proteins.
• Proven leadership of technical programs and client-facing activities.

Responsibilities

• Provide scientific leadership for downstream program strategy and execution.
• Design and optimize chromatography, UF/DF, viral clearance and filtration steps.
• Lead technology transfer and scale-up for cGMP manufacturing readiness.
• Partner with clients to align technical execution with program goals.
• Mentor scientists and cross-functional teams toward project milestones.
• Ensure GDP-compliant documentation and regulatory readiness.

Skills

Scientific leadership

Client-facing

Project management

Education

Ph.D. in Biotechnology or related

M.S. in a relevant field

B.S. in a relevant field

Tools

Chromatography

UF/DF

Filtration

Viral clearance

Cell removal

Job description

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

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.
• 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.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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