Senior Director, External Manufacturing International Commercial Operations – Cell and Genetic [...]

Senior Director, External Manufacturing International Commercial Operations – Cell and Genetic Therapies

Job Description

The Senior Director of Cell and Genetic Therapies External Manufacturing ex-US Commercial Operations plays a critical role within the External Manufacturing department at Vertex responsible for managing Vertex-CDMO partnerships to ensure that the company effectively and efficiently delivers our CGT medicines to patients. This role will engage directly with key internal functional areas (eg Supply Chain, MSAT, CMC-Regulatory, Quality Control, Quality Assurance, Labeling) to ensure KPI’s and information needs are understood and met. The role will support CMSC Supply Chain in interactions with Vertex internal Commercial and other related stakeholder groups to manage S&OP expectations, track drug product batch deliverables, and facilitate resolution of operational priorities.

This role will supervise and work with Vertex ‘persons-in-plant’ and CDMO leadership to identify, prioritize and drive improvement opportunities; develop and manage KPIs and business processes; closely manage batch progress and data delivery along the patient journey. The role will be key in the escalation and management of deviations from the defined Commercial process, managing communication between the international CMSC and the CDMO-facing teams.

This role will need to cultivate and leverage multiple cross-functional business relationships to identify and develop effective mechanisms for managing and communicating information pertaining to the manufacturing through release of product from our CDMO partners in a commercial environment. The Senior Director of External Manufacturing ex-US Commercial Operations will be based in Vertex’s London offices (Paddington) and reports directly to the Vice President of External Manufacturing Cell and Genetic Therapies. This role will partner closely with colleagues across Vertex Quality, Regulatory and CMSC departments and will be part of the Regional CMSC Supply Chain team to ensure seamless supply of all ex-US clinical and commercial CGT products. The Senior Director-level grading for this role reflects the need for a strategic thinker who is able to navigate fast-moving, high-pressure environments and manage complex stakeholder needs.

This is a hybrid position based in Paddington, London (3 days a week in the office required).

Key Responsibilities:

• Partner closely with internal stakeholders, providing leadership and guidance during development and implementation of CGT manufacturing, supply, logistics and commercialization strategies.
• Establish and lead internal and CDMO governance (internal: Virtual Plant Team; external: joint project team, joint steering committee, partner with QA on QMR, etc).
• Main point of contact for Vertex stakeholders responsible for commercialization of CGT products outside of the US. Responsibilities include providing leadership for operational planning (eg lifecycle management timing, new market introduction changes), prioritization, progress status and delivery of information from Vertex CDMO’s to Vertex’s Commercial organization. This also includes close partnership with launch and lifecycle management teams.
• Identify opportunities for continuous improvement of CDMO throughput, robustness, data-management, etc without disrupting day-to-day operations.
• Responsible for identifying business risks through the manufacturing value chain, working proactively with relevant stakeholders to negotiate mitigations, manage these risks and assure supply continuity for delivery against commitments.
• Track and communicate execution of the production plan at CGT CDMOs, with appropriate escalation of impactful quality or operational deviations/excursions impacting planned production. Ensure capacity increases are delivered on time.
• Proactive leadership in resolution of issues impacting manufacturing and supply is required, engaging internal and CDMO stakeholders to drive to resolutions. Escalate appropriately to internal and/or joint governance if required.
• Assist VP 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 expectations by disciplined tracking of activities for delivery against objectives; managing changes (documentation, alignment); monitoring and tracking performance (KPIs and metrics).
• 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.
• Responsible for partnering with Quality 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. This includes alignment on the launch strategy and input into allocation of manufacturing capacity within the region.
• 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:

• Significant years of progressive experience in key leadership/management roles in biologics or CGT therapy development, clinical and commercial manufacturing and commercialization.
• Strong understanding of the technical aspects of manufacturing, testing, controls, and the regulations governing ATMP operations.
• Strong understanding of financial and supply chain systems in CGT operations.
• Proven years of experience as main point of contact for commercial strategy and business operations.
• 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.
• Knowledge of regulations related to implantable medical devices would be an advantage.
• A strategic thinker, results-orientated and having a sense of urgency to deliver high-quality outcomes on time and in a highly ethical and professional manner.
• Motivated leader within a global, highly matrixed environment; the ability to articulate vision and successfully drive execution is key for this senior level role.
• 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 site.
• 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 20% of time.

Preferred Requirements:

• Bachelor’s 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.
• MBA with technology or commercial asset management.
• Experience in commercialization of new assets and management of post-approval lifecycle.

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.