Director, Manufacturing Operations, Cell and Gene Therapy Operations

General

Summary:

The Director, External Manufacturing Cell and Genetic Therapies oversees and manages Vertex’s cell and gene therapy Contract Manufacturing Organizations (CMOs) to implement the cGMP supply strategy across the clinical to post-approval lifecycle. Partners with internal and external teams to support technology transfer, process qualification, and commercial readiness, including seamless supply of clinical and post-approval products. Leads strategy execution and operations at key Vertex C(D)
MO partners; collaborates with process development, Quality, QC, Supply Chain, and others. Based in Boston, MA (Seaport). May travel up to 50% to C(D)
MO sites.

• Lead CMC, manufacturing/supply, logistics, and commercialization strategy execution with internal stakeholders.
• Drive CGT production plan execution at C(D)
  MOs (SOW through delivery).
• Lead and develop a cross-functional team; recruit, train, and qualify staff for commercialization and routine operations.
• Manage Persons-in-Plant (PIPs) to oversee operational execution.
• Identify/escalate contract and business issues; track delivery against objectives; manage change and performance metrics.
• Scrutinize C(D)
  MO systems/processes; assess and mitigate risks to ensure supply continuity.
• Co-lead C(D)
  MO governance meetings; drive issue resolution and appropriate escalation.
• Support C(D)
  MO due diligence; participate in contract negotiation and act as contract monitor post-execution.
• Provide regulatory filing input (IND/BLA) and drive operations-focused pre-approval inspection and readiness.
• Partner with Quality to ensure compliance with regulatory requirements and champion quality culture.
• Foster a winning culture through transparent communication and engagement.

• Highly preferred: experience in a biologics or CGT manufacturing plant.
• Strong cGMP and aseptic processing knowledge; implantable device regulations advantageous.
• Strong understanding of manufacturing/testing/controls; pharmaceutical ops regulations; financial systems; contract management.
• Proven primary leadership in CDMO relationships and outsourced manufacturing contractual relationships.
• Strategic, results-oriented, ethical; motivational leadership in a global matrixed environment.
• Excellent cross-functional communication; hands‑on problem solving and contingency planning.
• Resilient in fast‑paced, ambiguous environments; sound judgment and business acumen.
• Travel up to 50%.

• Bachelor’s and/or advanced degree in Life Sciences relevant to cell/gene therapy (e.g., immunology, cell biology, genetic engineering), ideally with senior cGMP manufacturing leadership.
• 10+ years progressive leadership/management experience in biologics/CGT development and clinical manufacturing.