Senior Upstream Process Engineer - Biologics MS&T

Catalent Pharma Solutions; Alabama; On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Paid time off

8 holidays

Benefits from day one

Tuition reimbursement

Job summary

Catalent Pharma Solutions is seeking a Senior Process Engineer in Madison, WI for Manufacturing Sciences & Technology, Upstream Technology Transfer. You will drive technology transfer from development to GMP manufacturing, model processes, assess facility fit, and author critical documentation.

This onsite role emphasizes cross‑functional collaboration and strong leadership in a cGMP setting. The position requires extensive experience in biologics manufacturing, including mammalian cell culture

Qualifications

• Associate degree in STEM with 12+ years of related experience or Bachelor’s in STEM with 6+ years, or Master’s with 4+ years, or Doctorate in STEM without formal industry experience.
• Experience in mRNA product development, mRNA manufacturing, protein therapeutics manufacturing, and late-stage/commercial manufacturing.
• Experience authoring, revising, and reviewing technical documentation including reports, SOPs, and batch records, supported by statistical data analysis.
• Proven leadership experience managing and mentoring staff, including cross-functional training.
• Hands-on experience investigating and resolving deviations, OOS events, change controls, and CAPAs in a cGMP environment.
• Technical expertise in upstream biologics manufacturing processes (e.g., mammalian cell culture, in vitro transcription).

Responsibilities

• Oversee technology transfer between external clients or Process Development and Manufacturing.
• Collaborate with engineers and scientists to drive facility fit and technical transfer of mammalian biologic processes.
• Review statements of work and ensure projects stay within scope.
• Author and review technical documents such as protocols, transfer reports, SOPs, and batch records.
• Lead or support cross-functional teams across Process Development, Manufacturing, QA, and other departments.
• Provide training and mentorship on technical topics and project management.

Skills

Technology transfer

Process modeling

Cross-functional collaboration

Leadership

cGMP compliance

Single-use systems

Statistical data analysis

Mammalian cell culture

Education

Associate’s degree in STEM

Bachelor’s degree in STEM

Master’s degree in STEM

Doctorate in STEM

Tools

Statistical data analysis

Molecular biology

Job description

Catalent Pharma Solutions is seeking a Senior Process Engineer in Madison, WI for Manufacturing Sciences & Technology, Upstream Technology Transfer. You will drive technology transfer from development to GMP manufacturing, model processes, assess facility fit, and author critical documentation.

This onsite role emphasizes cross‑functional collaboration and strong leadership in a cGMP setting. The position requires extensive experience in biologics manufacturing, including mammalian cell culture