Director, Manufacturing Operations, Cell and Gene Therapy Operations

Scorpion Therapeutics; Boston (MA); On-site; USD 230,000 - 290,000; Full time

Job summary

Vertex in Boston, MA is seeking a Director, External Manufacturing Cell and Genetic Therapies to oversee and manage CMOs across the clinical to post-approval lifecycle. The role partners with internal teams to support tech transfer, process qualification, and commercial readiness.

You will lead strategy execution, ensure supply continuity, and drive governance meetings with CDMO partners while traveling up to 50% to CMOs. The position requires strong leadership in CGT/biologics manufacturing.

Qualifications

• Bachelor’s or advanced degree in Life Sciences relevant to cell/gene therapy.
• 10+ years progressive leadership/management in biologics/CGT/manufacturing.
• Strong cGMP and aseptic processing knowledge.

Responsibilities

• Lead CMOs to execute commercial readiness and supply strategy.
• Drive CGT production plan execution at CMOs (SOW through delivery).
• Lead and develop cross-functional team; recruit and train staff for commercialization.

Skills

CGT manufacturing

cGMP

Regulatory knowledge

Leadership

Contract manufacturing

Cross-functional collaboration

Travel 50%

Education

Bachelor’s or advanced degree in Life Sciences

Senior cGMP leadership experience

Tools

Quality Management Systems

Project management software

Financial systems

Job description

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.

Key Duties and Responsibilities:

• 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.

Knowledge and Skills (Qualifications):

• 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%.

Education and Experience:

• 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.