Job Description

General Summary:

The Strategic Program Leader (SPL, Casgevy) will provide leadership of the CMC agenda for the Casgevy program within Biopharmaceutical Sciences and Manufacturing Operations (BSMO). Casgevy is a CRISPR-derived genetic therapy that treats the underlying cause of Sickle Cell Disease and transfusion-dependent Beta-Thalassemia, and is the world’s first CRISPR-based therapy to be commercially approved. This role will report to the VP of Manufacturing Science and Technology (MSAT) for Cell and Gene Therapies within the Commercial Manufacturing and Supply Chain (CMSC) division. The role will be based in Boston.

Key Responsibilities

The SPL (Casgevy) will oversee the development and execution of the CMC strategy for the program which includes the following:

• Represent BSMO on the Disease Strategy Team (DST) to ensure CMC plans are fully integrated into the overall programmatic strategy. The role will provide leadership over the cross-functional CMC team within BSMO and ensure that the team drives the program agenda consistent with the overall program strategy.
• Leads the development of yearly operating budgets and objectives and longer-term strategic plans.
• Represents BSMO for critical decisions and strategic interactions with the Executive Committee (EC).
• Works closely with BSMO leadership (including Finance) to communicate progress and proactively escalates issues with Disease Area Executive (DAE), the BSMO Lead Team and the EC.
• Builds a long-term manufacturing and supply chain strategy and roadmap, prioritizing key projects and investments encompassing product launches, post-approval enhancements and lifecycle management plans, process and method technical changes, sourcing and scale up activities, robustness/quality and productivity projects.
• Ensures manufacturing capacity and network strategies are in place to meet product demand and COGs targets globally, including expansion into new global markets. Leads this effort while working closely with the Commercial, Manufacturing Operations and Supply Chain teams.
• Working with the Manufacturing Sciences and Technology (MS&T) and Process Development (PD) teams to develop and implement a comprehensive CMC technical lifecycle management plan. This includes process and method improvements, as well as integrating new product development and pipeline programs into the overall program portfolio.
• Anticipates future industry trends and keep abreast with a strong foundational of knowledge of manufacturing, development, and supply.

Education And Experience

• B.S. or BA in science and/or engineering (biotechnology, biology, chemistry, pharmacy, engineering or related sciences). Masters or advanced degree (sciences or business) preferred.
• 15+ years extensive experience and demonstrated leadership in Manufacturing and Supply Chain Management and/or Process Development with a significant component in manufacturing, development or supply.
• Prior experience supporting CMC for cell and gene therapies and/or biologics.
• Capability to build cross-functional alignment including R&D, Process Development, Regulatory, Finance, and Manufacturing partners.
• Excellent verbal, written and presentation skills and effectively communicate with all levels of management, including to Executive Committee members at the highest levels of the organization.
• Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrix environment.
• Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.

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.

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 ApplicationAssistance@vrtx.com.