Senior Associate - Biomanufacturing, Compliance - Manufacturing Technical Support

Senior Associate in Biomanufacturing Compliance and Manufacturing Technical Support at Catalent, onsite in Madison, WI, delivering end-to-end technical support in a cGMP environment with emphasis on incident response, tech transfer, and continuous improvement.

Responsibilities

• Serve as incident commander during rapid response, delivering real-time troubleshooting and technical guidance for manufacturing operations.
• Collaborate with clients and cross-functional teams across Process Development, Manufacturing, QA/QC, Supply Chain, Project Management, and Facilities to enable tech transfer, monitor process performance, and drive project delivery.
• Author and oversee batch documentation, ensuring GMP-compliant execution and providing strategic manufacturing support.
• Analyze process data, present project updates, identify trends, and generate internal and client-facing reports.
• Identify optimization opportunities for processes and equipment, and support business case development for improvements.
• Support deviations, change controls, and CAPAs, including root cause analysis, impact assessments, and implementation of corrective actions.
• Act as a technical subject matter expert, coaching teammates and expanding overall team capability.
• Partner with engineers and scientists to ensure facility readiness, enable process transfer, and sustain operational excellence.
• Contribute to site and network initiatives as needed.
• Other duties as assigned.

Requirements

• Minimum education: Associate degree in STEM with 6+ years of related experience; a Bachelor’s with 3+ years or a Master’s with at least 1 year of related experience is preferred.
• 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: ability to see, hear, read, and write clear English; frequent sitting, standing, walking, reading documents, and using a computer; occasional stooping, kneeling, crouching, bending, carrying or grasping; frequent lifting up to 10 pounds and occasional up to 50 pounds; must comply with EHS responsibilities.

Technologies

• Single-use systems

Benefits

• Defined career path and annual performance reviews
• Diverse, inclusive culture
• Potential for career growth on an expanding team dedicated to preserving and improving lives
• 152 hours of PTO plus 8 paid holidays
• Generous 401K matching
• Medical, dental, and vision benefits
• Tuition reimbursement

Position Details

• Work Schedule: Alternating 3/4-4/3 weekly schedule with core hours 11:00 PM – 10:00 AM
• Location: On-site in Madison, WI
• On-call rotation required and compensated