Manufacturing Operations Lead (cGMP & Batch Records)

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

Job summary

Vertex Pharmaceuticals Incorporated in Boston is seeking a Supervisor, Manufacturing Operations to lead first, second, or third-shift manufacturing activities and ensure compliant, efficient execution of cGMP operations on the floor.

The role requires a Bachelor's degree in a scientific/technical field, 6+ years of experience with supervisory responsibilities, and experience in cell therapy/aseptic manufacturing. On-site schedule with strong cross-functional collaboration.

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 the 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.
• Leading and Attending Teir 0 and Tier 1 meetings.
• Perform other duties and projects as assigned to meet departmental requirements.

Education

Bachelor's degree in scientific, technical or engineering discipline

Tools

POMS MES

Job description

Vertex Pharmaceuticals Incorporated in Boston is seeking a Supervisor, Manufacturing Operations to lead first, second, or third-shift manufacturing activities and ensure compliant, efficient execution of cGMP operations on the floor.

The role requires a Bachelor's degree in a scientific/technical field, 6+ years of experience with supervisory responsibilities, and experience in cell therapy/aseptic manufacturing. On-site schedule with strong cross-functional collaboration.