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

Advanced Manufacturing Tech Solutions; St. Louis (MO); On-site; USD 140,000 - 200,000; Full time

Job summary

Advanced Manufacturing Tech Solutions seeks a Process Lead to guide the MES project, ensuring bioprocess manufacturing is accurately captured, optimized, and embedded in a GMP-regulated MES environment.

You will map workflows, design MES requirements, and collaborate with manufacturing, quality and MES teams to implement robust, harmonized processes across operations and support go-live readiness and training.

Qualifications

• 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.

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.

Skills

Bioprocess manufacturing

Process mapping

Leadership

Stakeholder management

GMP knowledge

Education

B.S. 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.

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