Vice President, Commercial Manufacturing - Bedford - Stoke Therapeutics

    Stoke Therapeutics
    Stoke Therapeutics Bedford

    1 week ago

    Description
    About Stoke:
    Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Using Stoke's proprietary approach, the company is developing antisense oligonucleotides (ASOs) to selectively restore naturally occurring protein levels. Stoke's first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke entered into a strategic collaboration with Biogen in 2025 to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights
    STK-002 is Stoke's proprietary antisense oligonucleotide (ASO) in clinical development for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. STK-002 has been granted orphan drug designation by the FDA. A Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. The company is also conducting early research in Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.
    Stoke's initial focus is on diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company's proprietary approach.
    Position Purpose:
    The Vice President, Commercial Manufacturing - Rare Diseases is responsible for the strategic and operational leadership of all commercial manufacturing activities supporting the company's rare disease portfolio. This executive will ensure reliable, compliant, and cost-effective production of highly specialized oligonucleotide therapies. The VP will lead external manufacturing networks to ensure product availability for patients with critical unmet medical need. This position will report into the SVP, Chemistry and Manufacturing.
    Key Responsibilities:
    Strategic & Operational Leadership
    • Develop and execute a comprehensive commercial manufacturing strategy aligned with the company's mission to deliver therapies for rare and ultra-rare diseases, maintaining appropriate levels of inventory to meet/exceed demand.
    • Oversee technology transfer from late-stage development into commercial GMP production, ensuring scalability and robustness for niche patient populations.
    • Interface with internal SMEs to support manufacturing operations and potential investigations or troubleshooting of ongoing manufacturing activities.
    Quality, Compliance & Regulatory
    • Ensure all manufacturing activities meet or exceed global regulatory standards (FDA, EMA, PMDA, MHRA, etc.).
    • Partner with Quality and Regulatory Affairs to maintain GMP compliance, validation, and audit readiness.
    • Embed a culture of safety, quality, and continuous improvement throughout all operations.
    Supply & Lifecycle Management
    • Direct supply planning and capacity management to ensure uninterrupted global supply for commercial and compassionate-use programs.
    • Support product lifecycle management, including post-approval process optimization and change control.
    • Manage risk mitigation and business continuity strategies for specialized therapies and limited-source materials.
    Financial & Business Leadership
    • Develop and manage operating budgets, capital investment plans, and cost optimization programs without compromising quality or compliance.
    • Support strategic business decisions, as well as corporate partnerships.
    Required Skills & Experience:
    • Advanced degree in Engineering, Biochemistry, Chemistry, Pharmaceutical Sciences, or related field; MBA and/or PhD preferred.
    • 15+ years of experience in pharmaceutical or biopharmaceutical manufacturing, with at least 8 years in senior operational leadership roles.
    • Recent NDA experience, including authorship of module 3 for submission.
    • Recent commercialization experience.
    • Demonstrated experience with rare disease products (oligonucleotide modalities would be a plus).
    • Deep understanding of GMP regulations and quality systems supporting GMP commercial manufacturing
    • Strong leadership, strategic planning, and cross-functional collaboration skills.
    • Exceptional communication and executive presence, with a track record of influencing internal and external stakeholders.
    Location(s):
    Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is a hybrid position, currently based in Bedford and will later be based in Waltham.
    Travel:
    This position will require approximately 30% travel.
    Compensation & Benefits:
    At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.
    The anticipated salary range for this role is $320,000 - $355,000 The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.
    Our benefits package includes medical, dental and vision insurance; life, long and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).
    Culture & Values:
    At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual's needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.
    Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.
    Interested candidates: Please visit Stoke's website to learn more and apply directly to the position listed on our Career Center:

    For more information, visit
    All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.

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