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Job Details


Vertex

External Manufacturing Senior Director, Cell and Genetic Therapies

Sales and Related

All

Full Time

On Site

No

Boston, Massachusetts, United States

Job Description

The External Manufacturing Senior Director of Cell and Genetic Therapies, plays a critical role within the External Manufacturing department at Vertex responsible for managing CDMO partnerships to ensure that the company effectively and efficiently delivers medicines to patients. This role is directly responsible for engaging with Vertex internal groups to develop a deep understanding of the process development, CMC and clinical status and priorities, provide input to the CMC strategy and manage execution of the process, CMC and clinical strategy at external partners. Additionally, this role will lead internal virtual plant teams, managing remote process engineer/person-in-plant employees as needed to oversee operations at the CDMOs, and co-lead joint project governance teams with CDMO’s. This role will need to cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to manufacturing opportunities and challenges within our CDMO partners en route to commercialization and launch of the Vertex asset.

The External Manufacturing Senior Director of Cell and Genetic Therapies, reports directly to the Executive Director of External Manufacturing Cell and Genetic Therapies and leads the strategy execution and operations team at key Vertex CDMO partners. This position will be based in Vertex’s corporate headquarters in Boston, MA. This role will partner closely with colleagues across Vertex development, Quality and CMSC departments to ensure seamless supply of all clinical and commercial products. The Senior Director-level grading for this role reflects the need for a strategic thinker who is able to negotiate difficult conversations with, and drive performance at, the CDMOs and who can distil trade-off decisions into recommendations for escalation to leadership. This role is ultimately accountable for successful execution of the program at the CDMO’s.

Key Responsibilities:

  • Partner closely with internal stakeholders, providing leadership and guidance during development of the CMC, manufacturing and supply, logistics and commercialization strategies.
  • Main point of contact for identified Vertex CDMO’s, specialized cell-processing and transduction equipment providers and critical material needs. This includes leading joint Vertex-CDMO working teams and co-chairing Joint Steering Committees
  • Long-term strategic supplier management and accountable for SRM and SRM-related processes for the relevant CGT contract network
  • Responsible for driving execution of the production plan at CGT CDMOs. (PO through delivery).
  • Lead a high performing global team by recruiting and developing talent, ensuring the development and implementation of training required to fully qualify staff for commercialization and routine operations.
  • Assist Head of CGT External Manufacturing in prioritizing, developing and implementing systems, processes and tools to ensure that the External Manufacturing group can manage the Vertex CGT pipeline and commercial programs through launch and beyond; setting the group up for success. Management, training and development of the program team will be a key factor in ensuring our people feel engaged, we optimize CDMO oversight, and the new systems/tools are embedded.
  • Manage multiple Persons-in-Plant (PIPs) as needed to drive and oversee production plan.
    • Identify and escalate business/contract issues.
    • Manage expectations by disciplined tracking of activities for delivery against objectives; managing changes (documentation, alignment); driving performance (metric setting, monitoring).
    • Scrutinize CDMO systems and processes related to Vertex programs, identifying risks and negotiating mitigations to assure supply continuity and delivery against demand requirements.
    • Coordinate, manage and co-lead CDMO governance meetings, in partnership with CDMO program manager and/or business lead.
    • Drive issue resolution, escalating appropriately to internal and/or joint governance if required.
    • As needed, partner with Strategic Sourcing for CDMO due diligence during new CDMO selection to vet capabilities, risks and investments required.
    • Engage, as needed, in contract negotiation and review. After execution of a contract, act as contract monitor, ensuring both Vertex and the CDMO comply with commitments.
  • Provide significant CDMO-focused regulatory filing input (IND, BLA, etc) and drive operations-focused pre-approval inspection and commercial readiness activities at the CDMOs
  • Responsible for partnering with Quality and CMSC Strategy and Business Operations to be the champions of the culture of quality with our CDMO’s and to ensure that all activities and documentation comply with regulatory requirements
  • Partner with Supply Chain and Manufacturing Science and Technology teams to develop and implement long term manufacturing network strategies, maintaining a flexible, reliable, robust, and cost-effective manufacturing network.
  • Partner with the Strategic Product Leader to manage and coordinate post-approval lifecycle strategy implementation, including establishing a robust business continuity program with strategic CDMOs.
  • Strengthen a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement

Minimum Requirements:

  • Bachelor’s and/or advanced degree in Life Sciences discipline appropriate to cell and gene therapy programs (immunology, cell biology, genetic engineering, etc), ideally in a senior manufacturing leadership role working with or in cGMP facilities within the biotechnology or pharmaceutical industry
  • 15+ years progressive experience in key leadership/management roles in biologics or CGT therapy development, clinical and commercial manufacturing.
  • Strong understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing pharmaceutical operations, as well as financial systems, contract management and controls
  • At least 5 years demonstrated experience as main point of contact in CDMO relationships
  • Experience working in a biologics or CGT manufacturing plant highly preferred
  • Demonstrated understanding of the development and management of contractual relationships for outsourced manufacturing operations
  • Strong knowledge of cGMP and aseptic processing requirements; knowledge of regulations related to implantable medical devices would be an advantage
  • A strategic thinker, results-orientated and 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 entrepreneurial 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 25% of time

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [Register to View]