Senior Associate - Biomanufacturing, Compliance - Manufacturing Technical SupportPosition Summary:- Work Schedule: Alternating 3/4-4/3 Weekly Schedule, core hours 11pm-10am
- 100% on-site (Madison, WI)
- On-call rotation required (compensated)
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. The team's capabilities span solution preparation, cell banking, upstream and downstream processing, mRNA and molecular therapeutics, and small-scale fill/finish. Operating through integrated Process Execution and Process Compliance teams, Manufacturing ensures safe, right-first-time batch delivery while embedding continuous improvement to optimize processes, increase efficiency, and expand capacity. This collaborative model enables strong on-the-floor support, rapid issue resolution, and consistent adherence to compliance standards which creates a high-impact, growth-oriented environment for professionals in biomanufacturing.
The Role:- 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.
The Candidate:- Must have a minimum of Associate's degree in STEM with 6+ years of related experience. It is preferred to have a Bachelor's with 3+ years or Master's with at least 1 year of related experience.
- Related experience encompasses 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: Individual must be 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 and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities.
Why you should join Catalent:- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of PTO + 8 paid holidays
- Generous 401K match
- Medical, dental and vision benefits
- Tuition Reimbursement - Let us help you finish your degree or start a new degree!
