Director, CMC Lead

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 TANGO (Targeted Augmentation of Nuclear Gene Output) approach, the company develops antisense oligonucleotides (ASOs) to selectively restore naturally occurring protein levels. The first drug in development, zorevunersen, has shown disease‑modifying potential in patients with Dravet syndrome and is currently in a Phase 3 study.

Stoke’s initial focus is on central nervous system and eye diseases caused by haploinsufficiency, with proof of concept extending to other organ systems. The company is headquartered in Bedford, Massachusetts. Learn more.

The team is seeking an experienced Director, CMC Lead to lead cross‑functional teams accountable for chemistry, manufacturing, and controls (CMC) product lifecycle management. The individual will serve as the single point of accountability for all CMC activities, from early development through regulatory approval and commercial lifecycle management, and will shape the technical and operational direction of their assigned programs.

• Provide technical and strategic leadership to cross‑functional CMC development teams for early and late‑phase programs.
• Define, own, and maintain a long‑term development, manufacturing, and supply strategy for assigned programs, covering early and late‑stage CMC development, process validation, commercial readiness, product launch, and post‑approval lifecycle management.
• Set the strategic direction for primary container closure and delivery device selection (e.g., pre‑filled syringe).
• Partner with Manufacturing and Supply Chain to ensure capacity and network strategies support clinical and commercial demand.
• Identify and lead the assessment of technical, regulatory, quality, logistical, and financial risks associated with CMC development, manufacturing, and supply, and develop mitigation strategies.
• Represent CMC on Program Teams, serving as the primary CMC voice in governance.
• Develop long‑range technical strategies to enable CMC delivery against Program Team objectives.
• Lead commercial product CMC lifecycle activities, including post‑approval change management, product risk management, robustness improvements, and continuous improvement initiatives.
• Drive the creation of integrated commercial readiness plans to enable global regulatory submissions and product launches.
• Cross‑functional review and approval of critical product‑related documents:
• IND/IMPD, NDA/MAA, meeting briefing documents and other regulatory documents
• Scale‑up and tech transfer protocols
• Pharmacy Manual
• Comparability plans/reports
• Justification of Specifications
• Process characterisation and validation documentation
• Commercial Process Control Strategy
• Serve as a senior technical authority in health‑authority interactions and regulatory filings for combination products.
• Author and review relevant sections of regulatory filings, including INDs, IND amendments, and BLAs.
• Provide coaching and mentoring to CMC core team members.

• Bachelor’s degree in biochemistry, chemical engineering, pharmaceutical sciences, or a related field; MS or PhD strongly preferred.
• 10+ years of progressive industry experience in CMC development, with significant direct experience with drug‑device combination products.
• Minimum 5 years of leadership experience within a CMC function in biologics, oligonucleotides, or advanced therapeutics.
• Experiential breadth across two or more technical functions (e.g., process development, analytical development, manufacturing, regulatory CMC, or quality).
• Demonstrated experience leading late‑stage development through commercial launch.
• Strong knowledge of QA and regulatory requirements for late‑stage manufacturing, including cGMP, ICH, FDA, and EMA guidelines.
• Broad understanding of CMC development and compliance across analytics, process development, manufacturing, regulatory CMC, and quality assurance.
• Track record of leading and aligning cross‑functional technical teams in a matrixed organization.
• Experience authoring…