Senior Manufacturing Ops Leader - cGMP & Cell Therapy

Vertex Inc.; Boston (MA); On-site; USD 139,000 - 209,000; Full time

Job summary

Vertex Inc. seeks a Senior Manager, Manufacturing Operations to lead a supervisory team and oversee day-to-day cGMP manufacturing activities.

This role ensures audit-ready facilities, drives continuous improvement, and aligns with production schedules, site objectives, and business priorities to produce pharmaceutical drug products. The position requires extensive leadership experience in pharmaceutical manufacturing, knowledge of cGMP, and a strong focus on safety, quality, and efficiency

Qualifications

• Bachelor’s degree in a scientific, technical, or engineering discipline.
• Typically requires 10+ years of experience or the equivalent combination of education and experience.
• Strong experience in direct people supervision in a cGMP manufacturing environment required.
• Significant leadership experience in pharmaceutical manufacturing operations within a cGMP-regulated environment required.
• Prior experience managing supervisors and/or manufacturing teams.
• Prior cell therapy and aseptic manufacturing experience.
• Prior POMS MES experience preferred.
• Experience supporting commercial and/or late-stage development manufacturing preferred.

Responsibilities

• Manage and develop a supervisory team, ensuring strong execution, accountability, and team effectiveness.
• Direct the activities of the group through management of staff, prioritization, and assignment of tasks.
• Responsible for aligning with site leadership to provide departmental and technical leadership.
• Assume a project leader role for departmental and interdisciplinary projects.
• Ensure work is prioritized, staffed, and executed in alignment with detailed production schedules and business needs.
• Oversee cGMP manufacturing activities, including equipment setup, assembly, operation, disassembly, cleaning, and associated support activities.
• Ensure compliant execution, review, and approval of batch documentation and other GMP records.
• Provide oversight for real-time on-the-floor batch record review and escalation of operational or compliance issues as needed.
• Participate in event investigations, CAPAs, and change controls in support of production and departmental objectives.
• Identify and continuously improve practices, procedures, and activities related to the department and site.
• Partner cross-functionally to support validation activities, facility readiness, investigations, and manufacturing objectives.
• Ensure the facility remains in an audit-ready state through adherence to procedures, documentation standards, and inspection readiness practices.
• Monitor and enforce GMP compliance for personnel, processes, and activities.
• Drive operational performance through tiered management systems, including leadership of Tier 1 and/or Tier 2 meetings and follow-up on escalated issues.
• Monitor manufacturing performance metrics and trends; identify risks and drive actions to improve safety, quality, delivery, and cost.
• Enable the timely achievement of departmental, site, and corporate goals.
• Mentor, motivate, coach, and evaluate the performance of group members.
• Foster interdisciplinary communication, collaboration, and shared understanding within the group and across departments.
• Ensure personal and team compliance with all training requirements.
• Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
• Perform other duties and projects as assigned to meet departmental and business requirements.

Skills

Leadership

People management

Mentoring

Communication

cGMP principles

Cell therapy manufacturing

Process validation

CAPA

Change control

QbD

DoE

SPC

GMP systems

Training compliance

Education

Bachelor’s degree

Tools

QDoCCS

Job description

Vertex Inc. seeks a Senior Manager, Manufacturing Operations to lead a supervisory team and oversee day-to-day cGMP manufacturing activities.

This role ensures audit-ready facilities, drives continuous improvement, and aligns with production schedules, site objectives, and business priorities to produce pharmaceutical drug products. The position requires extensive leadership experience in pharmaceutical manufacturing, knowledge of cGMP, and a strong focus on safety, quality, and efficiency