Scientist – Process Development, Drug Substance Lifecycle
Catalent
Summary
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.
Job description
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.
Requirements
- 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
- 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
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Tuition Reimbursement
- Professional Development
- Paid Time Off
- Holiday Schedule
Company overview
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) that serves as a trusted partner to pharmaceutical, biotech, and consumer health companies worldwide. Founded on a legacy dating back to 1933, Catalent has evolved into a comprehensive drug development and delivery leader with over 40 global sites. The company specializes in providing end-to-end solutions spanning oral dose formulations, biologics, specialty products, and clinical supply services. Catalent's expertise includes formulation development, analytical services, commercial manufacturing, and advanced delivery technologies such as Zydis® fast-dissolve tablets and softgel technologies. With over 1,000 active development programs at any given time, the company launches more than 100 new products and line extensions annually and has supported half of all FDA approvals over the past decade. Catalent produces over 60 billion treatment doses per year, helping approximately 200 million patients annually. Headquartered in Tampa, Florida, the company employs more than 10,000 professionals globally who are dedicated to putting patients first and championing the missions that matter in healthcare innovation.