Lead Scientist, Downstream Process Development - Biologics

Catalent Pharma Solutions; Alabama; On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical, dental, and vision

401(k) with company match

Tuition reimbursement

Paid time off

Job summary

Catalent's Madison, Wisconsin facility seeks a Principal Scientist to lead downstream process development for mAbs, multispecifics and recombinant proteins, with ~25% hands-on lab work and the majority focused on technical leadership and program management.

You will guide teams through chromatography, UF/DF, filtration, and viral clearance, drive technology transfer to cGMP manufacturing, and partner with clients to ensure project success.

Qualifications

• Ph.D. in Biotechnology, Biochemical Engineering, Chemical Engineering, Biology or related field with 8+ years of industry experience; or master's with 12+ years; or bachelor's with 15+ years.
• Demonstrated expertise in development and commercialization of mAbs, multispecifics, recombinant proteins or other complex biologics.
• 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.
• Knowledge of cGMP environments, technology transfer, process characterization, and scale-up.
• Excellent scientific communication, problem-solving, and project management skills.

Responsibilities

• Technical Leadership & Scientific Strategy: lead downstream process development programs for mAbs, multispecifics, and recombinant proteins.
• Process Development Oversight: design, develop, optimize, and characterize downstream processes for clinical and commercial manufacturing.
• Client Partnership & Program Management: act as primary technical contact for client projects, lead meetings, report status, and align execution with objectives.
• Technology Transfer & Commercial Readiness: lead transfer activities, scale-up, characterization studies, and viral clearance programs.
• Cross-Functional Leadership: collaborate with Process Development, MS&T, Manufacturing, Quality, and Analytical teams.
• Technical Documentation & Review: author/review SOPs, protocols, reports, batch records, and client deliverables per GDP.
• Innovation & Continuous Improvement: evaluate new technologies and advance scientific capabilities.
• Mentorship & Scientific Development: mentor scientists and staff.
• Other responsibilities as needed.

Skills

Process development

Downstream

Leadership

Project management

cGMP

Technology transfer

Chromatography

UF/DF

Viral clearance

Cell removal

Education

PhD in Biotechnology/biochemical/chemical biology

Master's degree with 12+ years experience

Bachelor's degree with 15+ years experience

Job description

Catalent's Madison, Wisconsin facility seeks a Principal Scientist to lead downstream process development for mAbs, multispecifics and recombinant proteins, with ~25% hands-on lab work and the majority focused on technical leadership and program management.

You will guide teams through chromatography, UF/DF, filtration, and viral clearance, drive technology transfer to cGMP manufacturing, and partner with clients to ensure project success.