Biomanufacturing Compliance Lead - On-site, Madison

Catalent Pharma Solutions; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

152 hours PTO + 8 holidays

401K match

Medical, dental and vision benefits

Tuition reimbursement

Job summary

Catalent, Inc. in Madison, WI is seeking a Senior Associate for Biomanufacturing Compliance to support 3/4-4/3 alternating shifts on-site.

You will lead incident responses, troubleshoot in real time, and partner with Process Development, Manufacturing, QA/QC, Supply Chain, and Facilities to ensure compliant GMP execution and successful tech transfer. Responsibilities include data analysis, project updates, CAPAs, deviations, and change controls.

Qualifications

• Must have a minimum of 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.
• 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.

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.

Skills

Biomanufacturing

Technical writing

Statistical methods

Troubleshooting

Tech transfer

cGMP compliance

Cross-functional collaboration

Process optimization

Education

Associate’s degree in STEM

Bachelor’s degree in STEM

Master’s degree in STEM

Job description

Catalent, Inc. in Madison, WI is seeking a Senior Associate for Biomanufacturing Compliance to support 3/4-4/3 alternating shifts on-site.

You will lead incident responses, troubleshoot in real time, and partner with Process Development, Manufacturing, QA/QC, Supply Chain, and Facilities to ensure compliant GMP execution and successful tech transfer. Responsibilities include data analysis, project updates, CAPAs, deviations, and change controls.