Stoke Therapeutics · 2 months ago
Vice President, Commercial Manufacturing – Rare Diseases
Bedford, Massachusetts, United States
Full-time
Hybrid
Director/Executive
$320K/yr - $355K/yr
15+ years expStoke Therapeutics is a biotechnology company focused on restoring protein expression through RNA medicine. The Vice President, Commercial Manufacturing – Rare Diseases will lead all commercial manufacturing activities for the company's rare disease portfolio, ensuring reliable and compliant production of oligonucleotide therapies.
BiotechnologyHealth CarePharmaceuticalTherapeutics
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
Qualification
Required
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
Preferred
MBA and/or PhD preferred
Demonstrated experience with rare disease products (oligonucleotide modalities would be a plus)
Benefits
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
Participation in our Employee Stock Purchase Program (ESPP)
Company
Stoke Therapeutics
Stoke is developing antisense oligonucleotide medicines that target RNA splicing to increase gene expression for treatment.
51-200 employees
H1B Sponsorship
Stoke Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (2)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$360.1MKey Investors
Apple Tree Partners
2024-03-27Post Ipo Equity· $125M
2020-11-24Post Ipo Equity· $105.1M
2019-06-19IPO
Leadership Team
Edward Kaye
CEO & Founder
Adrian Krainer
Co-founder & Director
Recent News
BioWorld Financial Watch
2026-01-15
2026-01-13
2026-01-12
Company data provided by crunchbase