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 technical expertise and 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. 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: 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. Required Qualifications:PhD in a STEM discipline or Master's degree with a minimum of 3 years of relevant industry experience; or Bachelor's degree with a minimum of 6 years of relevant industry experience. Preferred Qualifications: Experience supporting biologics development, characterization, validation, or commercial manufacturing. Knowledge of process characterization, PPQ, lifecycle management, and validation principles. Experience working within cGMP environments. Familiarity with statistical analysis tools such as JMP, Minitab, or Excel. Experience supporting cross-functional technical projects and client-facing activities. 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 Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to View email address on click.appcast.io. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to View email address on click.appcast.io for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.SummaryLocation: Madison, WIType: Full time