Global MSAT DS Senior Process Steward

About the role

The Global MSAT DS Senior Process Steward connects MSAT expertise with manufacturing sites worldwide, supporting process industrialisation and ensuring compliance across large‑molecule drug substance operations.

Key responsibilities

• Support Product Technical Leads and Product Stewards in process gap assessments, risk integration and mitigation strategy development.
• Drive systematic process and supply improvements, including second‑source and change strategies.
• Execute validated state support activities, respond to evolving conditions and ensure compliance (e.g., VICs, RCAs).
• Provide technical expertise for engineering runs, investigations, CAPAs and troubleshooting; lead non‑product specific RCAs.
• Leverage pilot‑plant resources for validation studies and process transfers.
• Implement network initiatives aligned with site plans, material changes and health‑authority requirements.
• Collaborate with global and site functions, serving as a digital enabler for technical sustainability improvements.

Required profile

• B.S. or M.S. in Chemical/Biochemical Engineering or related field with 7+ years of industrial experience; PhD advantageous.
• Experience in collaborative, matrix‑team leadership and decision‑making.
• Deep expertise in E. coli systems; experience with CHO processes is a plus.
• Familiarity with pharmaceutical quality systems, regulatory submissions and health‑authority requirements.
• Advanced communication skills and willingness to travel up to 10%.

Required skills

• E. coli process systems
• CHO process knowledge
• Process development and engineering
• Process validation and technology transfer
• Pharmaceutical quality systems