Manufacturing Operations Lead — cGMP & Batch Records

Vertex Inc.; Boston (MA); On-site; USD 98,000 - 147,000; Full time

Job summary

Vertex is seeking a Supervisor, Manufacturing Operations to lead on-site manufacturing activities on an afternoon/evening schedule. You will assign work, supervise shift personnel, and ensure compliant, efficient execution in a cGMP environment.

Training lasts ~90 days across Cambridge and Leiden facilities. Candidates should have a scientific/engineering background with 6+ years’ leadership experience and prior cell therapy experience.

Qualifications

• Bachelor’s degree in a scientific, technical or engineering discipline.
• 6+ years of experience or the equivalent combination of education and experience.
• Prior supervisory or leadership experience preferred.
• Prior cell therapy and aseptic manufacturing experience preferred.
• Prior POMS MES experience preferred.

Responsibilities

• Lead and supervise daily manufacturing operations.
• Assign work to shift personnel based on detailed production schedules and plans.
• Oversee cGMP activities including equipment setup, assembly, operation, disassembly, and cleaning.
• Execute and witness batch record instructions to ensure compliant documentation.
• Interface with cross-functional teams to support facility operations and objectives.
• Ensure GMP compliance and audit readiness of the facility.
• Lead Tier 0 and Tier 1 meetings and drive continuous improvement.
• Maintain training compliance and lead on-site teams.

Skills

Leadership

Team coaching

Communication

Project management

cGMP knowledge

SOP familiarity

Analytical thinking

Education

Bachelor’s degree in scientific/engineering discipline

6+ years experience

Prior supervisory or leadership experience preferred

Prior cell therapy and aseptic manufacturing experience preferred

Prior POMS MES experience preferred

Tools

POMS MES

Job description

Vertex is seeking a Supervisor, Manufacturing Operations to lead on-site manufacturing activities on an afternoon/evening schedule. You will assign work, supervise shift personnel, and ensure compliant, efficient execution in a cGMP environment.

Training lasts ~90 days across Cambridge and Leiden facilities. Candidates should have a scientific/engineering background with 6+ years’ leadership experience and prior cell therapy experience.