Senior Biomanufacturing Compliance & Tech Support (On-Site)

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

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.