MSAT Specialist - Technology Transfer (Cell Culture or Purification)

Pauwels Consulting; Geel; On-site; EUR 70,000 - 100,000; Full time

Job summary

Pauwels Consulting seeks an expert to provide scientific support for commercial manufacturing and process optimization within a pharma setting. The role focuses on technology transfers, documentation readiness, and data-driven process improvements at a GMP manufacturing site.

You will lead technical studies, validate control strategies, and work across development and production to ensure robust introduction of new products and processes.

Qualifications

• PhD with 3+ years or Master's with 5+ years in process development or MSAT.
• Hands-on experience with mammalian cell culture or purification at lab/manufacturing scale.
• Solid understanding of GMP and statistical data trending techniques.
• Fluent in English.
• Flexible team player with strong interpersonal skills and ability to adjust to shifting priorities.
• Detail-oriented with excellent analytical skills for technical manufacturing challenges.

Responsibilities

• Support the technology transfer of new drug substance manufacturing processes from development laboratories to large-scale GMP facilities.
• Ensure documentation readiness by conducting process fit-gap analyses, defining control strategies, and preparing sampling plans.
• Lead process improvement initiatives to increase yield and robustness while generating supportive data packages for implementation.
• Provide technical support for commercial manufacturing processes through data trending, monitoring, and investigation of deviations.
• Develop scientific study protocols and reports to support significant process changes and product impact assessments.

Skills

MSAT

Process development

Mammalian cell culture

Purification

GMP

Data trending

Statistical analysis

English

Education

PhD in a relevant field

Master's degree in a relevant field

Tools

JMP

Statistica

Matlab

Simca

Job description

Our client, a leading pharmaceutical organization, is seeking an expert to provide scientific support for commercial manufacturing and process optimization. The project focuses on facilitating technology transfers and ensuring the robust introduction of new products and processes at a manufacturing site.

• Support the technology transfer of new drug substance manufacturing processes from development laboratories to large-scale GMP facilities.
• Ensure documentation readiness by conducting process fit-gap analyses, defining control strategies, and preparing sampling plans.
• Lead process improvement initiatives to increase yield and robustness while generating supportive data packages for implementation.
• Provide technical support for commercial manufacturing processes through data trending, monitoring, and investigation of deviations.
• Develop scientific study protocols and reports to support significant process changes and product impact assessments.

• You have a PhD with 3+ years or a Master's degree with 5+ years of relevant experience in process development or MSAT.
• You bring hands‑on experience with mammalian cell culture or purification processes at laboratory or manufacturing scale.
• You possess a solid understanding of Good Manufacturing Practices (GMP) and statistical data trending techniques.
• You're a flexible team player with strong interpersonal skills and the ability to adjust to shifting priorities.
• You're detail-oriented with excellent analytical skills for identifying and addressing technical manufacturing challenges.
• You are fluent in English.

Nice to Haves

• Prior experience working in a GMP environment.
• Experience with statistical software such as JMP, Statistica, Matlab, or Simca.