Scientist – Process Development, Upstream

Catalent is seeking Scientists, Process Development – Upstreamto support the development, optimization, characterization, and transfer of mammalian cell culture processes for biologicsmanufacturing. Scientists in this role may support projects across multiple development stages, including early-phase process development, process characterization,validationreadiness, and clinical/commercial manufacturing support.

Successful candidates may be assigned to different upstream development teams based on business needs and experience. Opportunities include supportofearly-stage process development programs as well as late-phase process characterization, validation, and commercial manufacturing initiatives.

The successful candidate will combine strong laboratoryexpertisewith data analysis, technical problem-solving, technical writing, and cross-functional collaboration to deliver high-quality process solutions for internal and client programs.

About Catalent Madison

Catalent's Madison, Wisconsin facility isa state-of-the-artbiologicsdevelopment 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 proprietaryGPEx® andGPEx® 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 globalbiologicsnetwork while supporting Wisconsin's growing life sciences industry.

Location:100% Onsite at our facility in Madison, Wisconsin
Shift:Monday – Friday, First Shift

Key Responsibilities

• Design and execute upstream process development studies supportingbiologicsprograms 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,validationreadiness, and technology transfer activities using platform methods and statistical tools, including Design of Experiments (DOE).

• Analyze experimental data and communicate results through presentations, technical recommendations, and project updates.

• Maintain GMP-compliant documentation and author or review technical documents including protocols, reports, SOPs, and regulatory-supporting documentation.

• Serve as a technical resource for internal teams and external clients by communicating project progress, presenting results, and supporting project execution.

• Contribute to continuous improvement initiatives, laboratory operations, and the training and mentoring of junior team members.

• Other responsibilities as needed.

Required Qualifications

• Bachelor's degree in a STEM discipline with a minimum of 6 years relevant experience,Master'sdegree 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 relatedbiologicsdevelopment activities.

• Ability to independently design, execute, analyze, and troubleshoot complex experiments in a fast-paced environment.

• 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,identifyprocess improvements, and recommend technical solutions.

• Proficiencywith Microsoft Office applications and laboratory or manufacturing software systems.

Preferred Qualifications

• Experience in upstream biologics process development, process characterization, or process optimization.

• Experience with technology transfer, validation support, scale-up, or commercial manufacturing programs.

• Working knowledge of statistical analysis tools and Design of Experiments (DOE).

• Experience with automated small-scale bioreactor systems such as Ambr® 250or similar technologies.

• Experience authoring technical reports, protocols, and regulatory-supporting documentation.

• Experience in a GMP-regulated biopharmaceutical, biotechnology, or CDMO environment.

• Previousclient-facing experience.

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 companymatch

• 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.

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