Catalent, Inc
Scientist - Process Development, Upstream
Madison, WI
Sponsorship not specifiedDetected 6 days ago
Data AnalysisStatisticsProcess ImprovementClinical TrialsGMPCell CultureResearchCollaborationProblem SolvingMentoringPublic SpeakingWritingMicrosoft Office
About the role
- 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.
Responsibilities
- Design and execute upstream process development studies supporting biologics programs from early development through commercial readiness.
- Perform mammalian cell culture activities including cell bank thawing, seed train expansion, bioreactor operations, and analytical testing.
- Support process optimization, process characterization, scale-up, validation readiness, and technology transfer activities using platform methods and statistical tools, including Design of Experiments (DOE).
- Maintain GMP-compliant documentation and author or review technical documents including protocols, reports, SOPs, and regulatory-supporting documentation.
Requirements
- 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.
- Experience with upstream process development, mammalian cell culture, bioreactor operations, or related biologics development activities.
- Strong understanding of GMP documentation practices, data integrity requirements, and technical writing, including protocols, reports, and SOPs.
- Demonstrated analytical and problem-solving skills with the ability to interpret data, identify process improvements, and recommend technical solutions.
- Proficiency with Microsoft Office applications and laboratory or manufacturing software systems.
Nice to have
- Experience in upstream biologics process development, process characterization, or process optimization.
- Experience with technology transfer, validation support, scale-up, or commercial manufacturing programs.
- Experience with automated small-scale bioreactor systems such as Ambr® 250 or similar technologies.
- Experience authoring technical reports, protocols, and regulatory-supporting documentation.
- Experience in a GMP-regulated biopharmaceutical, biotechnology, or CDMO environment.
- Previous client-facing experience.
- Why you should join Catalent
- Opportunity to play a key role in driving growth within a global CDMO leader.
Skills
- Scientist - Process Development, Upstream
- Successful candidates may be assigned to different upstream development teams based on business needs and experience.
- About Catalent Madison
Compensation
- Competitive compensation package, including incentive opportunity.
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