Vice President, Commercial Manufacturing - Rare Diseases

Stoke Therapeutics, Inc.•Bedford, MA

58d•$320,000 - $355,000•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

MBA and/or PhD preferred.
Demonstrated experience with rare disease products (oligonucleotide modalities would be a plus).

Responsibilities

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.
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.
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.
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.