Director, Manufacturing Operations, Cell and Gene Therapy Operations
$184,000–$276,000 year
On-siteBoston, Massachusetts, United States
Job Summary
Oversee and manage Vertex's critical cell and gene therapy Contract Manufacturing Organizations (CMOs), defining and managing ongoing cGMP supply from clinical through post-approval lifecycle. Lead strategy execution at key C(D)MO partners by driving production plan execution, managing Persons-in-Plant oversight, and coordinating governance meetings to ensure seamless supply of clinical and commercial products. Partner with internal stakeholders to develop CMC, manufacturing, and commercialization strategies while resolving operational issues and negotiating contract terms. Provide regulatory filing input for IND and BLA submissions, drive pre-approval inspection readiness, and champion a culture of quality compliance across C(D)MO operations. Travel up to 50% of time to C(D)MO sites as a Person-in-Plant or Subject Matter Expert to support technical resolution and program initiatives.
Required Qualifications
- Bachelor's and/or advanced degree in Life Sciences discipline appropriate to cell and gene therapy programs (immunology, cell biology, genetic engineering, etc)
- 10+ years progressive experience in key leadership/management roles in biologics or CGT therapy development, and clinical manufacturing
- Bachelor's degree
- Advanced degree
- Life Sciences discipline
- Immunology
- Cell biology
- Genetic engineering
- Leadership/management roles
- Biologics
- CGT therapy development
- Clinical manufacturing
Desired Qualifications
- Experience working in a biologics or CGT manufacturing plant
- Strong knowledge of cGMP and aseptic processing requirements
- Knowledge of regulations related to implantable medical devices
- Strong understanding of the technical aspects of manufacturing, testing and controls
- The regulations governing pharmaceutical operations
- Financial systems
- Contract management
- Demonstrated experience as a primary leader in CDMO relationships
- Demonstrated understanding of the development and management of contractual relationships for outsourced manufacturing operations
- A strategic thinker
- Results-orientated
- A having a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
- Motivational leadership of a cohesive high-performing team within a global, highly matrixed environment
- The ability to articulate vision and successfully drive execution
- Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor
- Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address
- Resilient and able to work well in a demanding, fast-paced and ambiguous environment
- Sound judgment and business acumen with personal versatility and flexibility as business and team evolve
- Keeps current on professional knowledge, expertise and best practice
- Able to travel, national and international, up to 50% of time during key periods of program activity
- Ideally in a senior manufacturing leadership role working with or in cGMP facilities within the biotechnology or pharmaceutical industry
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