Process Lead MES - Biopharma

The Process Lead will bring strong bioprocess manufacturing expertise to the MES project, making sure manufacturing processes are accurately captured, optimized and built into the MES solution within a GMP-regulated environment.

Key Responsibilities

• Lead the process workstream of the MES project, from process mapping through go-live.
• Map and analyze bioprocess manufacturing workflows (upstream and downstream) and translate them into MES requirements.
• Partner with manufacturing, quality and MES teams to design MBR / EBR recipes that reflect real shop-floor operations.
• Drive process harmonization and standardization across operations.
• Support testing, validation and user acceptance to make sure solutions meet GMP and operational needs.
• Support operational readiness, training and adoption at go-live.

Requirements

• Degree in chemical / biochemical engineering, life sciences or a related discipline.
• 10+ years’ experience in biopharmaceutical / bioprocess manufacturing, in process engineering or operations leadership.
• Hands-on involvement in MES implementation projects (e.g., PAS-X, Syncade, PharmaSuite, Opcenter).
• Strong understanding of upstream and downstream bioprocess operations.
• Sound knowledge of GMP, batch record practices and data integrity.
• Strong leadership, facilitation and stakeholder management skills.
• Based in, or willing to relocate to, St. Louis, Missouri, and authorized to work in the US.

[email protected]