Scientist – Process Development, Downstream

Catalent • Madison, WI

43d • Onsite

About The Position

Catalent is hiring Scientists in Process Development – Downstream to develop, optimize, characterize, and transfer purification processes for biologics manufacturing. Opportunities span Early-Phase Process Development and Technology Transfer & Scale-Up Support; candidates will be matched to the team best aligned with their background and career goals. The role combines hands-on protein purification laboratory expertise with data analysis, technical problem-solving, technical writing, and cross-functional collaboration to deliver process solutions for internal and client programs.

The position is based 100% onsite at Catalent’s biologics development and manufacturing facility in Madison, Wisconsin, which supports customers from research through early- and mid-stage clinical production. The facility specializes in mammalian cell line engineering, drug substance manufacturing, and biopharmaceutical process development, with production capabilities from 50L to 4,000L.

The schedule is Monday through Friday on first shift.

Requirements

• Bachelor’s degree in a STEM discipline with at least 6 years of relevant experience, a master’s degree with at least 3 years of relevant experience, or a PhD with relevant academic experience.
• Hands-on experience with process-scale chromatography and filtration, including chromatography, tangential flow filtration, and normal flow filtration.
• Experience operating, maintaining, and troubleshooting chromatography workstations and process skids, such as ÄKTA platforms.
• Knowledge of protein purification principles, methods, scale-up concepts, and chromatography modes.
• Working knowledge of Good Documentation Practices (GDP), aseptic techniques, and technical document authoring, including protocols, SOPs, batch records, and reports.
• Ability to independently design, execute, analyze, and troubleshoot complex laboratory experiments under accelerated timelines.
• Proficiency with Microsoft Office applications, including Excel and Word, and laboratory or manufacturing software systems.

Nice To Haves

• Experience in early-stage biologics process development, clone or candidate screening, method adaptation, or process optimization.
• Direct experience with technology transfer into cGMP manufacturing, scale-up parameters, viral clearance validation, or process characterization.
• Experience in a cGMP-regulated biopharmaceutical, biotechnology, or CDMO environment.
• Experience using quality systems to track deviations, investigations, and change controls.
• Demonstrated experience mentoring and training junior scientific staff.
• Excellent client-facing and communication skills, including experience leading technical project discussions and client updates.

Responsibilities

• Independently perform downstream purification experiments, including automated chromatography on ÄKTA platforms, filtration, clarification, column packing, and tangential flow filtration (TFF/UF/DF).
• For early-phase process development, develop and optimize novel downstream purification methodologies, applying platform concepts and screening techniques to establish robust early-stage processes for client candidates.
• For technology transfer and scale-up, lead technology transfer activities into cGMP manufacturing, and execute scale-up studies, process characterization, viral clearance validation, and pilot-scale non-GMP engineering runs.
• Serve as technical lead for client development or transfer projects, communicating project status, technical rationales, and experimental results internally and externally.
• Author, review, and maintain GMP-compliant technical documents, including protocols, SOPs, test reports, and batch production records (BPRs), in accordance with Good Documentation Practices (GDP).
• Analyze complex experimental data using sound scientific judgment.
• Help train, coach, and mentor junior team members on laboratory procedures.
• 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 + 8 holidays).
• Collaborative, mission-driven culture focused on improving patient outcomes worldwide.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior