Manufacturing Operations Supervisor — cGMP On-Site Leader

Vertex Inc.

Boston (MA)

On-site

USD 98,000 - 147,000

Full time

4 days ago
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Job summary

Vertex Inc. is seeking a Supervisor, Manufacturing Operations to lead first, second, or third‑shift manufacturing activities, assign work per schedules, and ensure compliant, efficient execution of cGMP manufacturing tasks on the floor.

You will oversee equipment setup, assembly, operation, disassembly, and cleaning, review batch records in real time, and coordinate with QA, maintenance, and cross‑functional teams to meet production goals.

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 operational plans.
  • Oversee cGMP manufacturing activities, including equipment setup, assembly, operation, disassembly, and cleaning.
  • Execute and witness batch record instructions during cGMP operations to ensure accurate and compliant manufacturing documentation.
  • Performs real-time on the floor batch record review.
  • Interface with cross-functional teams to support facility operations, maintenance activities, and manufacturing objectives.
  • Monitor and enforce GMP compliance for all personnel and activities within the Drug Product facility.
  • Maintain the facility in an audit-ready state through adherence to procedures, documentation standards, and inspection readiness practices.
  • Ensure compliance with SOPs, policies, and work instructions to support safe and successful facility operation.
  • Work with QA Document Control to request, receive, and return MBRs for process operations.
  • Demonstrate Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
  • Maintain personal and team compliance with all ongoing training requirements.
  • Lead and attend Tier 0 and Tier 1 meetings.
  • Perform other duties and projects as assigned to meet departmental requirements.

Skills

Leadership
cGMP
Batch records
Cross-functional
Communication

Education

Bachelor's degree in a scientific, technical or engineering discipline

Tools

POMS MES

Job description

Vertex Inc. is seeking a Supervisor, Manufacturing Operations to lead first, second, or third‑shift manufacturing activities, assign work per schedules, and ensure compliant, efficient execution of cGMP manufacturing tasks on the floor.

You will oversee equipment setup, assembly, operation, disassembly, and cleaning, review batch records in real time, and coordinate with QA, maintenance, and cross‑functional teams to meet production goals.

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