Scientist - Process Development, Upstream

Scientist – Process Development, Upstream 
 

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

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

The successful candidate will combine strong laboratory expertise with 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 is a state-of-the-art biologics development 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 proprietary GPEx® and GPEx® 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 global biologics network 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 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). 

• 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'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. 

• 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, identify process improvements, and recommend technical solutions. 

• Proficiency with 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® 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.  

• 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. 

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