Process Lead – MES - Biopharma

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL); St. Louis (MO); On-site; USD 170,000 - 210,000; Full time

Job summary

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL) seeks a Process Lead to drive the MES implementation for bioprocess manufacturing in a GMP-regulated setting.

You will map processes, define MES requirements for upstream and downstream operations and collaborate with manufacturing, quality, and MES teams to ensure alignment with shop-floor realities. The role requires 10+ years in biopharmaceutical bioprocess, MES experience with PAS-X/Syncade/PharmaSuite/Opcenter, and the ability to lead

Qualifications

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

Responsibilities

• Lead the process workstream of the MES project from mapping through go-live.
• Map and analyze bioprocess workflows and translate into MES requirements.
• Design MBR/EBR recipes reflecting shop-floor operations with other teams.
• Drive process harmonization and standardization across operations.
• Support testing, validation and user acceptance to meet GMP and operational needs.
• Support readiness, training and adoption at go-live.

Skills

Bioprocess manufacturing

Leadership

GMP knowledge

Data integrity

Stakeholder management

Education

Chemical/biochemical engineering degree

Life sciences related discipline

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.