Scientist - Process Development, Upstream

About this role

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.  

​

Catalent offers rewarding opportunities to further your career!   Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Emp

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