Senior Upstream Process Engineer - Biologics Tech Transfer

Catalent; Madison (WI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

8 paid holidays

Job summary

Catalent is seeking a Senior Process Engineer in Madison, WI to lead technology transfer from development to GMP manufacturing for upstream biologics. You will partner with Process Development, Manufacturing, QA, and other functions to ensure robust, compliant transfer of mammalian processes.

Strong leadership and mentoring are required to drive projects and improvements. The role emphasizes cross-functional collaboration, documentation authority, and ongoing involvement in process optimization

Qualifications

• STEM degree with relevant experience in biologics
• Experience authoring technical documentation and reports
• Strong knowledge of cGMP and regulatory compliance
• Demonstrated leadership and mentoring capabilities

Responsibilities

• Oversee technical support of Manufacturing and technology transfer between Process Development and Manufacturing.
• Collaborate with engineers and scientists to drive facility fit and tech transfer of mammalian biologic processes.
• Evaluate equipment and process improvements for efficiency and scale-up.
• Support technology transfer of processes into manufacturing for internal and external programs.
• Prepare and review technical documents such as SOPs, transfer reports, batch records, and specifications.

Skills

Leadership

Cross-functional collaboration

Statistical data analysis

Technical mentoring

Education

Associate’s degree in STEM

Bachelor’s in STEM

Master’s in STEM

PhD in STEM

Job description

Catalent is seeking a Senior Process Engineer in Madison, WI to lead technology transfer from development to GMP manufacturing for upstream biologics. You will partner with Process Development, Manufacturing, QA, and other functions to ensure robust, compliant transfer of mammalian processes.

Strong leadership and mentoring are required to drive projects and improvements. The role emphasizes cross-functional collaboration, documentation authority, and ongoing involvement in process optimization