Senior Associate - Biomanufacturing, Compliance - Manufacturing Technical Support

Catalent Pharma Solutions; Alabama; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

152 hours of PTO + 8 paid holidays

Generous 401K match

Medical, dental and vision benefits

Tuition Reimbursement

Job summary

Catalent Pharma Solutions in Madison, WI seeks a Senior Associate for Biomanufacturing Compliance to drive end-to-end cGMP production support, process transfer, and quality assurance activities in a high-impact biologics environment.

The role emphasizes rapid incident command, problem solving, batch documentation, and collaboration with Process Development, QA/QC, and Manufacturing to ensure compliant, on-time delivery of therapeutic products.

Qualifications

• Must have an Associate’s degree in STEM with 6+ years of related experience.
• Bachelor’s with 3+ years or Master’s with at least 1 year of related experience.
• Experience applying statistical methods for data analysis, trending, and reporting to support process performance.

Responsibilities

• Lead rapid response as incident commander, providing real-time troubleshooting and technical support for manufacturing operations.
• Partner with clients and cross-functional teams 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.

Skills

Biomanufacturing knowledge

Statistical data analysis

Troubleshooting equipment

Tech transfer support

Documentation writing

Process improvement

GMP compliance

Education

Associate degree in STEM

Bachelor's degree

Master's degree

Tools

Single-use systems

Job description

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 263,000 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 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!
• Catalent offers rewarding opportunities to further your career!
• Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients across 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.

Equal Opportunity Employer

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 [e-mail]. 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.

About Catalent

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.