Senior Associate Biomanufacturing, Compliance Manufacturing Technical Support

Senior Associate - Biomanufacturing Compliance - Manufacturing Technical Support

Position Summary:

• 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 facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.

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 teams 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 Associates degree in STEM with 6 years of related experience. It is preferred to have a Bachelors with 3 years or Masters 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!

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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 . 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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.