Director, Manufacturing Operations, Cell and Gene Therapy Operations
Vertex Pharmaceuticals
September 02, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
Director overseeing and managing Vertex’s critical cell and gene therapy CDMOs and implementing the cGMP supply vision from clinical through post-approval lifecycle management. Partner with internal/external stakeholders to ensure technology transfer, process qualification, and commercial readiness. Travel up to 50% as a “Person-in-Plant” and/or SME.
Key Duties and Responsibilities:
- Lead execution of the production plan at CGT C(D)MOs (SOW through delivery).
- Partner with internal stakeholders on CMC, manufacturing/supply, logistics, and commercialization strategies.
- Lead and develop a cross-functional team; ensure qualification training for commercialization and routine operations.
- Manage Persons-in-Plant to oversee CMC, clinical, and commercial execution.
- Identify/escalate business and contract issues; track objectives and manage changes.
- Scrutinize C(D)MO systems/processes; identify risks and negotiate mitigations to ensure supply continuity.
- Coordinate/co-lead governance meetings; drive operational issue resolution and escalate appropriately.
- Support CDMO due diligence; engage in contract negotiation/review; act as contract monitor post-execution.
- Provide regulatory filing input (IND/BLA, etc.) and drive pre-approval inspection and commercial readiness.
- Partner with Quality to ensure compliance and establish a culture of quality at C(D)MOs.
Knowledge and Skills (Required/Preferred):
- Biologics/CGT manufacturing plant experience highly preferred.
- Strong cGMP and aseptic processing knowledge; implantable medical device regulations advantageous.
- Technical understanding of manufacturing/testing/controls, pharmaceutical regulations, financial systems, and contract management.
- Primary leadership experience in CDMO relationships; managing outsourced manufacturing contractual relationships.
- Strategic, results-oriented, ethical; strong people leadership and cross-functional communication.
- Problem-solving, contingency planning, resilience in fast-paced ambiguity.
- Travel up to 50%.
Education and Experience:
- Bachelor’s and/or advanced degree in Life Sciences (e.g., immunology, cell biology, genetic engineering), ideally in senior cGMP manufacturing leadership.
- 10+ years progressive leadership/management in biologics/CGT development and clinical manufacturing.
Director overseeing and managing Vertex’s critical cell and gene therapy CDMOs and implementing the cGMP supply vision from clinical through post-approval lifecycle management. Partner with internal/external stakeholders to ensure technology transfer, process qualification, and commercial readiness. Travel up to 50% as a “Person-in-Plant” and/or SME.
Key Duties and Responsibilities:
- Lead execution of the production plan at CGT C(D)MOs (SOW through delivery).
- Partner with internal stakeholders on CMC, manufacturing/supply, logistics, and commercialization strategies.
- Lead and develop a cross-functional team; ensure qualification training for commercialization and routine operations.
- Manage Persons-in-Plant to oversee CMC, clinical, and commercial execution.
- Identify/escalate business and contract issues; track objectives and manage changes.
- Scrutinize C(D)MO systems/processes; identify risks and negotiate mitigations to ensure supply continuity.
- Coordinate/co-lead governance meetings; drive operational issue resolution and escalate appropriately.
- Support CDMO due diligence; engage in contract negotiation/review; act as contract monitor post-execution.
- Provide regulatory filing input (IND/BLA, etc.) and drive pre-approval inspection and commercial readiness.
- Partner with Quality to ensure compliance and establish a culture of quality at C(D)MOs.
Knowledge and Skills (Required/Preferred):
- Biologics/CGT manufacturing plant experience highly preferred.
- Strong cGMP and aseptic processing knowledge; implantable medical device regulations advantageous.
- Technical understanding of manufacturing/testing/controls, pharmaceutical regulations, financial systems, and contract management.
- Primary leadership experience in CDMO relationships; managing outsourced manufacturing contractual relationships.
- Strategic, results-oriented, ethical; strong people leadership and cross-functional communication.
- Problem-solving, contingency planning, resilience in fast-paced ambiguity.
- Travel up to 50%.
Education and Experience:
- Bachelor’s and/or advanced degree in Life Sciences (e.g., immunology, cell biology, genetic engineering), ideally in senior cGMP manufacturing leadership.
- 10+ years progressive leadership/management in biologics/CGT development and clinical manufacturing.