Shift Lead, cGMP Biotech Manufacturing

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

Job summary

Vertex Inc. seeks a Supervisor, Manufacturing Operations to lead 1st–3rd shift production, assign work from schedules, and ensure compliant, efficient cGMP operations across the Drug Product facility.

You will oversee equipment setup, batch recording, QA interactions, and cross-functional collaboration, while maintaining audit readiness and safety. The role requires a BS in a scientific discipline and 6+ years of supervisory manufacturing 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 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.
• Leading and Attending Tier 0 and Tier 1 meetings.
• Perform other duties and projects as assigned to meet departmental requirements.

Skills

Leadership

Supervisory experience

cGMP knowledge

Manufacturing operations

Cell therapy

POMS MES

Education

Bachelor’s degree in scientific/technical/engineering

Tools

POMS MES

Job description

Vertex Inc. seeks a Supervisor, Manufacturing Operations to lead 1st–3rd shift production, assign work from schedules, and ensure compliant, efficient cGMP operations across the Drug Product facility.

You will oversee equipment setup, batch recording, QA interactions, and cross-functional collaboration, while maintaining audit readiness and safety. The role requires a BS in a scientific discipline and 6+ years of supervisory manufacturing experience.