Senior Associate - Biomanufacturing, Compliance - Manufacturing Technical Support

Work Schedule:

Alternating 3/4-4/3 Weekly Schedule, core hours 11pm-10am. 100% on‑site (Madison, WI). On‑call rotation required (compensated).

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO) located in Madison, WI. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single‑use systems to support scalable production. The Senior Associate for Biomanufacturing Compliance helps drive the end‑to‑end execution of clinical and commercial production in a cGMP environment, delivering high‑quality biologics in alignment with regulatory and client requirements.

• Lead rapid response as incident commander, providing real‑time troubleshooting and technical support for manufacturing operations.
• Partner with clients and cross‑functional teams (Process Development, Manufacturing, QA/ QC, Supply Chain, Project Management, Facilities) to support tech transfer, process performance, and project delivery.
• Author and oversee batch documentation, ensuring compliant GMP execution and providing strategic manufacturing support.
• Analyze and present process data, including project updates, trend identification, and internal/client reporting.
• Drive process and equipment improvements by identifying optimization opportunities and supporting business case development.
• Support deviations, change controls, and CAPAs, including root cause analysis, impact assessment, and corrective actions.
• Serve as a technical SME, coaching and developing team members while enhancing team capability.
• Collaborate with engineers and scientists to enable facility fit, process transfer, and ongoing operational excellence.
• Contribute to site and network initiatives as needed.
• Other duties as assigned.

• Minimum of an Associate’s degree in STEM with 6+ years of related experience. Preferred to have a Bachelor’s with 3+ years or a Master’s with at least 1 year of related experience.
• Strong technical writing and documentation skills, including authoring and revising SOPs, batch records, and reports.
• Experience applying statistical methods for data analysis, trending, and reporting to support process performance.
• Hands‑on experience operating and troubleshooting manufacturing equipment, including single‑use systems and consumables.
• Understanding of tech transfer, facility fit, and process scale‑up, with experience supporting late‑phase, PPQ, or commercial programs preferred.
• Broad bioprocess knowledge across upstream (cell culture), downstream (purification), and/or molecular therapeutics (e.g., mRNA) in cGMP environments.
• Physical requirements:
  
  Able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting up to 10 pounds and occasional lifting up to 50 pounds. Must comply with EHS responsibilities.

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team
• 152 hours of PTO + 8 paid holidays
• Generous 401(k) match
• Medical, dental and vision benefits
• Tuition reimbursement

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