Process Lead – MES (St. Louis, Missouri) - Biopharma

Advanced Manufacturing Tech Solutions (AMTSOL); St. Louis (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Advanced Manufacturing Tech Solutions (AMTSOL) seeks a Process Lead to drive the MES workstream for a bioprocess manufacturing program in a GMP environment. You will map, analyze and translate upstream/downstream workflows into MES requirements and design recipes reflecting real shop-floor operations.

The role requires 10+ years in biopharma process manufacturing, hands-on MES implementation, and strong leadership with cross-functional collaboration. Based in St.

Qualifications

• Degree in chemical/biochemical engineering or life sciences.
• 10+ years in biopharmaceutical/bioprocess manufacturing.
• Hands-on MES implementation experience (PAS-X, Syncade, PharmaSuite, Opcenter).
• Strong GMP, batch record and data integrity knowledge.
• Leadership and stakeholder management skills.

Responsibilities

• Lead the MES project process workstream from mapping to go-live.
• Map and analyze upstream and downstream bioprocess workflows for MES requirements.
• Design MBR/EBR recipes with manufacturing, quality, MES teams.
• Drive process harmonization and standardization across operations.
• Support testing, validation and user acceptance to meet GMP needs.
• Support readiness, training and go-live adoption.

Skills

Leadership

Stakeholder management

Process mapping

Cross-functional collaboration

Education

Bachelor's degree in chemical/biochemical engineering or life sciences

Tools

PAS-X

Syncade

PharmaSuite

Opcenter

Job description

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.