Scientist - Process Development, Upstream

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.

Responsibilities

• Design and execute upstream process characterization, optimization, and validation support studies for mammalian cell culture processes.
• Perform mammalian cell culture activities including cell bank thawing, seed train expansion, small-scale bioreactor operations, and analytical testing.
• Leverage statistical tools and Design of Experiments (DOE) methodologies to evaluate process performance and establish process understanding.
• Utilize scale-down models and automated bioreactor systems to support process characterization and commercialization activities.
• Analyze experimental data and prepare technical conclusions to support project decision-making and regulatory filings.
• Author and review technical documents including study protocols, reports, SOPs, and regulatory-supporting documentation.
• Collaborate closely with multidisciplinary teams supporting technology transfer, validation, manufacturing, and client programs.
• Contribute to continuous improvement initiatives and support training and mentoring activities within the department.
• Other responsibilities as needed.

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.
• 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 with process characterization, process validation, or commercial manufacturing support activities.
• Experience utilizing Design of Experiments (DOE) and statistical analysis tools.
• Experience with automated small-scale bioreactor systems such as Ambr® 250 or similar platforms.
• Experience supporting regulatory submissions or generation of regulatory-supporting technical documentation.
• Experience in a GMP-regulated biotechnology, pharmaceutical, or CDMO environment.
• Previous client-facing experience.

Benefits

• 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).

Pay

Competitive compensation package, including incentive opportunity.

Schedule

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