Qualifications
Responsibilities
Benefits
Scientist – Process Development, Downstream
Catalent is seeking Scientists, Process Development – Downstream to support the development, optimization, characterization, and transfer of purification processes for biologics manufacturing. We are currently hiring for opportunities focused on Early-Phase Process Development, as well as Technology Transfer & Scale-Up Support. Candidates will be evaluated for the team alignment that best matches their background and career goals.
Scientists in this role combine strong laboratory expertise in protein purification with data analysis, technical problem-solving, technical writing, and cross-functional collaboration to deliver high-quality process solutions for internal and client programs.
Location: 100% Onsite at our facility in Madison, Wisconsin
Shift: Monday – Friday, First Shift
Key Responsibilities:
Laboratory Execution: Independently perform downstream purification experiments, including automated chromatography (ÄKTA platforms), filtration, clarification, column packing, and tangential flow filtration (TFF/UF/DF).
Process Development & Optimization (Early-Phase Focus): Develop and optimize novel downstream purification methodologies, applying platform concepts and screening techniques to establish robust early-stage processes for client candidates.
Tech Transfer & Scale-Up (Tech Transfer Focus): Lead technology transfer activities into cGMP manufacturing, executing scale-up studies, process characterization, viral clearance validation, and pilot-scale non-GMP engineering runs.
Technical Leadership & Client Interaction: Serve as technical lead for client development or transfer projects, effectively communicating project status, technical rationales, and experimental results internally and externally.
Documentation & GMP Compliance: 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).
Data Analysis & Mentorship: Critically analyze complex experimental data using sound scientific judgment, while helping train, coach, and mentor junior team members on laboratory procedures.
Other responsibilities as needed.
Required Qualifications:
Bachelor's degree in a STEM discipline with a minimum of 6 years relevant experience, Master's degree with a minimum of 3 years relevant experience, or PhD with relevant academic experience.
Hands-on experience with process-scale chromatography and filtration (chromatography, tangential flow filtration, normal flow filtration).
Experience operating, maintaining, and troubleshooting chromatography workstations and process skids (e.g., ÄKTA platforms).
Demonstrated knowledge of protein purification principles, methods, scale-up concepts, and modes of chromatography.
Strong working knowledge of Good Documentation Practices (GDP), aseptic techniques, and technical document authoring (protocols, SOPs, batch records, reports).
Ability to independently design, execute, analyze, and troubleshoot complex laboratory experiments under accelerated timelines.
Proficiency with Microsoft Office applications (Excel, Word) and laboratory or manufacturing software systems.
Preferred Qualifications:
Experience in early-stage biologics process development, clone/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 for tracking deviations, investigations, and change controls.
Demonstrated experience mentoring and training junior scientific staff.
Excellent client-facing and communication skills, with experience leading technical project discussions and client updates.
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
About Catalent Pharma Solutions Inc
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