Senior Manufacturing Ops Leader - cGMP & Cell Therapy

Vertex Pharmaceuticals Incorporated

Boston (MA)

On-site

USD 139,000 - 209,000

Full time

4 days ago

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Job summary

Vertex Pharmaceuticals Incorporated is seeking a Senior Manager, Manufacturing Operations to lead a supervisory team and ensure safe, compliant, and efficient cGMP manufacturing operations in alignment with production schedules and business priorities.

You will drive continuous improvement, maintain an audit-ready facility, mentor staff, and partner cross-functionally on validation, deviations, CAPAs, and change controls to deliver high-quality drug products for patients.

Qualifications

Bachelor's degree in scientific/engineering field.
10+ years of supervision in cGMP manufacturing.
Cell therapy and aseptic manufacturing experience.
Experience in pharmaceutical manufacturing operations.
POMS MES experience preferred.
Experience supporting commercial and/or late-stage development manufacturing.

Responsibilities

Lead and develop a supervisory team for strong execution and accountability.
Direct activities through staffing, prioritization, and task assignment.
Align with site leadership for departmental and technical leadership.
Act as project leader for departmental and interdisciplinary initiatives.
Ensure work aligns with production schedules and business needs.
Oversee cGMP manufacturing activities and related support tasks.
Review and approve batch documentation and GMP records.
Provide on-the-floor batch record review and issue escalation.
Participate in investigations, CAPAs, and change controls.
Identify and improve practices and procedures within the department.
Partner cross-functionally on validation, readiness, investigations, and objectives.
Maintain audit-ready state through procedures and documentation.
Monitor GMP compliance for personnel, processes, and activities.
Drive performance via Tier 1/2 leadership and issue follow-up.
Monitor metrics, identify risks, and drive safety, quality, delivery, and cost actions.
Enable achievement of departmental and site goals.
Mentor and develop group members; foster collaboration.
Ensure training compliance for team members.
Demonstrate Vertex Phenotype behaviors and drive breakthrough results.