Senior Manager, GMP Quality Operations

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:

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 & 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:

• 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.
• Review and approve documentation generated at CMOs, including master batch records, deviations and investigations, process validation protocols/reports and change controls.
• Perform batch disposition of all GMP batches for release for further manufacturing.
• Compile necessary data and analyze metrics for compliance health checks for External Quality Business Review Meetings and Quality Management Review.
• 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.
• Support internal audit and external GMP vendor audits, as necessary, and work with Stoke staff to ensure the implementation of appropriate CAPAs.
• Support GMP regulatory inspections as SME, as necessary, and provide input and review of responses to regulatory agency questions resulting from these inspections.
• Provide GMP compliance technical support during regulatory inspections at Stoke's CMOs as necessary.
• Drafts and facilitates review and approval of Quality Agreements between CMOs/Suppliers and stoke, as needed
• Contribute to the development of Stoke's Quality culture.

Required Skills & Experience:

• 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.
• Strong working knowledge of relevant FDA, EU, ICH GMP regulations and guidelines with proficiency in interpreting and implementing GMPs in a practical manner.
• Experience in managing CMOs.
• Attention to detail with the…