Scientist - Process Development, Drug Substance Lifecycle

Scientist – Process Development, Drug Substance Lifecycle

Catalent is seeking a Scientist – Process Development, Drug Substance Lifecycle to join our team in Madison, Wisconsin. In this role, you will provide technicalexpertiseand lifecycle support for biologics programs as they progress through development, validation, commercialization, and post-approval manufacturing.

You’ll collaborate across Manufacturing, Quality, MS&T, Regulatory, Project Management, and client teams to drive successful program execution and continuous process improvement.

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.

100% Onsite at our facility in Madison, Wisconsin

Monday – Friday, First Shift

• Lead process characterization activities for development, validation, and commercial-stage biologics programs.
• Support process validation, continued process verification, comparability assessments, and lifecycle change management.
• Analyze process performance data,identify improvement opportunities, and drive risk reduction initiatives.
• Serve as a technical subject matter expert for assigned programs and client interactions.
• Author and review technical protocols, reports, validation documents, and regulatory support documentation.
• Support investigations, CAPAs, change controls, and quality system activities in a cGMP environment.
• Collaborate with cross-functional teams to ensure successful technology transfer and commercial manufacturing support.
• Other responsibilities as needed.

• PhD in a STEM discipline,or Master’s degree with a minimum of 3 years of relevant industry experience,or Bachelor’sdegree with a minimum of 6 years of relevant industry experience.

• Experience supportingbiologicsdevelopment, characterization, validation, or commercial manufacturing.
• Knowledge of process characterization, PPQ, lifecycle management, and validation principles.
• Experience working withincGMPenvironments.
• Familiarity with statistical analysis tools such as JMP, Minitab, or Excel.
• Experience supporting cross-functional technical projects and client-facing activities.

• 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.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a…