Principal Scientist, Biologics Process Development - Downstream Purification

Catalent Pharma Solutions; Madison (WI); Vor Ort; USD 180.000 - 230.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Medical, dental, vision coverage

401(k) with company match

Tuition reimbursement and professional

Generous paid time off and holidays

Zusammenfassung

Catalent Pharma Solutions is seeking a Principal Scientist in Biologics Process Development – Downstream Purification to lead late-stage purification program work and technology transfer for therapeutic proteins and antibodies. The role blends scientific leadership with client-facing activities across monoclonal antibodies, bispecifics, and recombinant proteins.

The Madison, WI facility emphasizes biologics development and manufacturing, offering opportunities to drive process improvements,

Qualifikationen

• Ph.D. or equivalent with extensive industry experience in biologics purification and downstream process development.
• Strong expertise in downstream purification unit operations including chromatography, UF/DF, filtration, viral clearance, and cell removal.
• Proven track record leading technical programs, client-facing interactions, and technology transfer in a biopharma/CDMO setting.

Aufgaben

• Serve as scientific lead for downstream process development programs (mAbs, bispecifics, recombinant proteins).
• Oversee design, optimization, characterization, and tech transfer of purification processes to support clinical and commercial readiness.
• Lead client interactions, project status reporting, and cross-functional collaboration across PD, MS&T, Manufacturing, QA, Regulatory, and Analytics.
• Drive technology transfer activities, process characterization, scale-up strategies, and viral clearance programs for cGMP manufacturing.
• Mentor scientists and staff; ensure GDP/compliant technical documentation.

Kenntnisse

Downstream purification

Chromatography

UF/DF

Viral clearance

Team leadership

CDMO experience

Ausbildung

PhD in Biotechnology / Biochemical Engineering / Chemical Engineering / Biology

Jobbeschreibung

Principal Scientist, Biologics Process Development - Downstream Purification

Catalent is seeking a Principal Scientist, Biologics Process Development - Downstream Purification to support late-stage biologics process development, technology transfer, and commercialization activities for therapeutic proteins and antibodies.

This is a highly visible, client-facing Process Development role supporting the advancement of biologics programs across a diverse portfolio of mAbs, bispecific antibodies, 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 purification process development activities including chromatography, UF/DF, filtration, viral clearance, and cell removal processes.

The successful candidate will bring significant industry experience in biologics purification and downstream process development, with a strong understanding of late-stage development, process characterization, technology transfer, and manufacturing readiness. Candidates should possess hands-on expertise in at least one of the following areas: monoclonal antibody (mAb) purification, bispecific antibody purification, or recombinant protein purification.

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), bispecific antibodies, and recombinant protein therapeutics. Provide strategic direction, scientific consultation, and technical oversight across multiple client programs, with a focus on purification process development, scale-up, technology transfer, and commercial readiness.
• Process Development Oversight: Guide the design, development, optimization, and characterization of downstream purification 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, process characterization studies, scale-up strategies, validation readiness initiatives, and viral clearance programs supporting progression from development through cGMP manufacturing and commercialization.
• Cross-Functional Leadership: Collaborate with Process Development, MS&T, Manufacturing, Quality, Regulatory, 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 industry experience developing, optimizing, scaling, and transferring downstream purification processes for monoclonal antibodies (mAbs), bispecific antibodies, recombinant proteins, or other complex biologic therapeutics.
• Strong expertise in chromatography, filtration, UF/DF, viral filtration, viral clearance, and cell removal technologies.
• Proven experience supporting late-stage development programs, process characterization studies, technology transfer activities, and commercial manufacturing readiness.
• Demonstrated experience operating within a biopharmaceutical, biotechnology, pharmaceutical, or biologics CDMO environment.
• Proven experience leading technical programs and serving as a client‑facing scientific representative.
• Demonstrated knowledge of cGMP environments, scale-up activities, and manufacturing support.
• Excellent scientific communication, problem‑solving, and project management skills.

Preferred Qualifications

• 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 Manufacturing Science & Technology (MS&T) and manufacturing operations teams during technology transfer and commercialization activities.

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 offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

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

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