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:
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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.
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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.
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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.
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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.
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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.
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Anticipates future industry trends and keep abreast with a strong foundational of knowledge of manufacturing, development, and supply.
Education and Experience:
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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.
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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.
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Prior experience supporting CMC for cell and gene therapies and/or biologics.
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Capability to build cross-functional alignment including R&D, Process Development, Regulatory, Finance, and Manufacturing partners.
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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.
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Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrix environment.
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Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
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Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives
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Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments
Pay Range:
$244,000 - $366,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
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 [email protected]
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What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
