Director, Manufacturing Operations, Cell and Gene Therapy Operations
Core
Oversee and manage Vertex's critical cell and gene therapy Contract Manufacturing Organizations (CMOs) to define and manage the cGMP supply of products from clinical through post-approval lifecycle.
Role type
Director, External Manufacturing Operations (Cell and Gene Therapy)
Builds
cGMP supply of cell and gene therapy products for clinical and commercial use
Domain
Biotechnology / Cell and Gene Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP and aseptic processing knowledge, contract management, supplier management, regulatory filing input, cross-functional leadership, strategic negotiation, operational issue resolution, team development
Preferred skills
biologics or CGT manufacturing plant experience, implantable medical device regulations knowledge, financial systems expertise
Technologies
cGMP facilities, regulatory filing systems (IND, BLA)
Responsibilities
Drive execution of production plans at C(D)MOs, manage Persons-in-Plant (PIPs) for operational oversight, lead cross-functional teams for talent development, coordinate C(D)MO governance meetings, provide regulatory filing input, scrutinize C(D)MO systems for risks, engage in contract negotiation and monitoring
Seniority
Director, strategic leadership with hands-on operational oversight