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<div class="content-intro">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.</div>Position Purpose: Sr. Manager, GMP Quality Operations will be the quality contract for quality oversight of GMP operations related to process tech-transfer, scale-up, process validation and manufacture drug substance and Drug product at Stoke’s CMOs. This individual will collaborate and partner closely with CMC department to ensure day-to-day activities maintain compliance with regulations in a phase appropriate manner. This role will report to the Director of Quality and will interface closely with other cross-functional groups such as CMC Manufacturing &amp; Analytical Development, Supply Chain, Regulatory CMC and other functions within Quality. The ideal candidate will have a strong working knowledge of relevant FDA, EU, ICH GMP, guidelines, and GMP regulations and experience working with CMOs and CTLs. It is preferred that this candidate have prior experience working with external vendors and in participating directly and indirectly in regulatory inspections. It is also preferred that this candidate has direct working knowledge of unit operations as it relates to Oligonucleotide Drug Substance manufacturing and process validation. A demonstrated ability to think outside of the box with a pragmatic risk-based approach for quality management is essential to this role. The candidate should be willing to directly contribute to the improvement of processes and resolution of issues as required. Key Responsibilities: <ul> <li>Oversee day-to-day management of outsourced GMP operations related to Drug product manufacturing at various CMOs to ensure successful and compliant execution of GMPs to meet regulatory requirements, guidelines, internal policies, and procedures.</li> <li>Review and approve documentation generated at CMOs, including master batch records, deviations and investigations, process validation protocols/reports and change controls.</li> <li>Perform batch disposition of all GMP batches for release for further manufacturing.</li> <li>Compile necessary data and analyze metrics for compliance health checks for External Quality Business Review Meetings and Quality Management Review.</li> <li>Represent quality on project teams, as needed and provide GMP compliance interpretation, consultation, and other supportive services necessary to maintain and improve compliance to ensure product quality, data integrity and patient safety.</li> <li>Support internal audit and external GMP vendor audits, as necessary, and work with Stoke staff to ensure the implementation of appropriate CAPAs.</li> <li>Support GMP regulatory inspections as SME, as necessary, and provide input and review of responses to regulatory agency questions resulting from these inspections.</li> <li>Provide GMP compliance technical support during regulatory inspections at Stoke’s CMOs as necessary.</li> <li>Drafts and facilitates review and approval of Quality Agreements between CMOs/Suppliers and stoke, as needed</li> <li>Contribute to the development of Stoke’s Quality culture.</li> </ul> Required Skills &amp; Experience:&nbsp; <ul> <li>BS/BA, MS in life sciences or chemistry with a minimum of 8+ years’ experience in Biotech or Pharma setting with direct experience in GMP Operations as it relates to either Oligonucleotide Drug Substance manufacturing, sterile fill finish operations.</li> <li>Strong working knowledge of relevant FDA, EU, ICH GMP regulations and guidelines with proficiency in interpreting and implementing GMPs in a practical manner.</li> <li>Experience in managing CMOs.</li> <li>Attention to detail with the ability to work within a multi-disciplinary team, as well as with external partners and vendors to establish strong and maintain a strong quality relationship.</li> <li>Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA</li> <li>Experience with drug substance and/or drug product (both preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting.</li> <li>Ability to work autonomously, provide QA/QC advice, effectively manage time, and deliver results on time.</li> <li>Ability to collaborate effectively in a dynamic, cross-functional matrix environment.</li> </ul> Desired Experience, Knowledge and Skills:&nbsp; <ul> <li>Experience in process validation for commercial product development.</li> <li>Proficient in using Veeva eQMS and Veeva Vault Quality.</li> <li>Prior experience in participating in regulatory inspections and responding to regulatory response.</li> <li>Ability to manage multiple projects in a fast-paced environment.</li> <li>Excellent organizational, interpersonal, verbal, and written communication skills.</li> <li>Conflict resolution/management and negotiation skills.</li> </ul> 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 with an office setting based in our Bedford, MA location. Travel: This position will require approximately 20% travel. Compensation &amp; 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&nbsp;$171,000 to $198,000.&nbsp;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).<div class="content-conclusion">Culture &amp; 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.&nbsp; Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center: <a href="https://www.stoketherapeutics.com/careers/">https://www.stoketherapeutics.com/careers/</a> For more information, visit https://www.stoketherapeutics.com/. 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. Stoke participates in E-Verify.</div>

Senior Manager, GMP Quality Operations

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Stoke Therapeutics

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