Director, Manufacturing Operations, Cell and Gene Therapy Operations

Vertex Inc.•Boston, MA

1d•$184,000 - $276,000•Hybrid

About The Position

The Director, External Manufacturing Cell and Genetic Therapies, role is to oversee and manage Vertex’s critical cell and gene therapy Contract Manufacturing Organizations (CMOs) and implement our vision for this business-critical function. The role requires a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products that supports clinical through post-approval lifecycle management. The ideal candidate will understand the challenges and make proactive operational decisions, taking into consideration cross-functional and patient impact. This role requires a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be able to travel up to 50% of their time during key program initiatives to C(D)MO sites as a “Person-in-Plant” to oversee activities on the ground, and/or as a SME to provide technical support to resolve emerging issues. The successful candidate will be a key member of the Vertex/CMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities. The External Manufacturing Director of Cell and Genetic Therapies, reports directly to the Senior Director of Manufacturing Operations Vertex Cell and Genetic Therapies and leads the strategy execution and operations team at key Vertex C(D)MO partners. This position will be based in Vertex's head office in Seaport, Boston MA. This role will partner closely with colleagues across process development, Quality, QC, Supply Chain and other functions to facilitate technology transfer, process qualification and commercial readiness at our C(D)MO’s, as well as seamless supply of all clinical and post-approval commercial products. The Director-level role reflects the need for a strategic thinker who is able to negotiate difficult conversations with, and drive performance at, the CDMOs.

Requirements

Experience working in a biologics or CGT manufacturing plant highly preferred
Strong knowledge of cGMP and aseptic processing requirements; knowledge of regulations related to implantable medical devices would be an advantage
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 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 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
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
10+ years progressive experience in key leadership/management roles in biologics or CGT therapy development, and clinical manufacturing.

Responsibilities

Partner closely with internal stakeholders, providing leadership and guidance during development of the CMC, manufacturing and supply, logistics and commercialization strategies.
Responsible for driving execution of the production plan at CGT C(D)MOs (SOW through delivery).
Lead a high performing cross-functional team, recruiting and developing talent as needed and ensuring the development and implementation of training required to fully qualify staff for commercialization and routine operations.
Manage Persons-in-Plant (PIPs) as needed to drive and oversee operational execution of the CMC, clinical and commercial plans at C(D)MOs.
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 C(D)MO 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 C(D)MO governance meetings, in partnership with C(D)MO program manager and/or business lead.
Drive operational issue resolution, escalating appropriately to internal and/or joint governance if required.
As needed, partner with Strategic Sourcing for C(D)MO due diligence during new supplier 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 C(D)MO comply with commitments.
Provide significant C(D)MO-focused regulatory filing input (IND, BLA, etc) and drive operations-focused pre-approval inspection and commercial readiness activities at the C(D)MO.
Responsible for partnering with Quality and other functions to be the champions of the culture of quality with our C(D)MO's and to ensure that all activities and documentation comply with regulatory requirements.
Create a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and people engagement.