Director, CMC Lead

Stoke Therapeutics•Bedford, MA

3d•$225,000 - $250,000•Hybrid

About The Position

Stoke Therapeutics is a biotechnology company focused on restoring protein expression using RNA medicine. Their proprietary TANGO approach utilizes antisense oligonucleotides (ASOs) to increase naturally occurring protein levels. The company's lead drug candidate, zorevunersen, is in Phase 3 development for Dravet syndrome, with a focus on central nervous system and eye diseases caused by haploinsufficiency. Stoke Therapeutics is headquartered in Bedford, Massachusetts.

Requirements

Bachelor's degree in biochemistry, chemical engineering, pharmaceutical sciences, or a related field required; advanced degree (MS or PhD) strongly preferred.
10+ years of progressive industry experience in CMC development, including significant direct experience with drug-device combination products (e.g. pre-filled syringes, autoinjectors, or similar parenteral delivery systems).
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, with deep knowledge of process and analytical method development, and validation lifecycles.
Strong working knowledge of QA and regulatory requirements for late-stage clinical and commercial manufacturing, including cGMP, ICH, FDA, and EMA guidelines.
Broad understanding of CMC development and compliance requirements across analytics, process development, manufacturing, regulatory CMC, and quality assurance.
Proven track record of leading and aligning cross-functional technical teams in a matrixed organization.
Proven experience authoring and leading CMC sections of global regulatory submissions, including INDs/IMPDs, BLAs/MAAs/JNDAs, and post-approval filings.
Excellent communication and interpersonal skills, with demonstrated ability to facilitate constructive problem-solving and drive decisions across functions and organizational levels.
Ability to manage multiple priorities, navigate ambiguity, and work effectively in a fast-paced, dynamic environment.

Responsibilities

Provide technical and strategic leadership to cross-functional CMC development teams accountable for one or more early- and late-phase programs.
Define, own and maintain a long-term development, manufacturing, and supply strategy for assigned programs, encompassing 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), guiding cross-functional risk assessments on drug-device compatibility, stability, and long-term performance to protect product quality and patient safety.
Partner with Manufacturing and Supply Chain to ensure manufacturing capacity and network strategies are in place to meet clinical and commercial demand.
Identify and lead the assessment of technical, regulatory, quality, logistical, and financial risks associated with CMC development, manufacture, and supply, and develop corresponding mitigation strategies.
Represent CMC on Program Teams for assigned products, serving as the primary CMC voice in the cross-functional program 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 including: 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 Characterization 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.