Director, CMC Lead
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AI Summary
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, Stoke 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’s initial focus are 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 Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/
Position Purpose:
The Stoke Therapeutics team is seeking an experienced and driven Director, CMC Lead to lead cross-functional teams that are accountable for chemistry, manufacturing, and controls (CMC) product lifecycle management. This individual will serve as the single point of accountability for all CMC activities, from early development through regulatory approval and commercial lifecycle management. This individual will play a central role in shaping the technical and operational direction of their assigned programs. The CMC Lead role is a highly visible matrix team leader that provides strategic and technical leadership within CMC, while representing CMC on cross-functional Program Teams.
The ideal candidate will possess strong knowledge of CMC leadership with deep understanding of process development, analytical methods, tech transfer, manufacturing, CMC regulatory strategy and health authority interactions. Additionally, this individual should possess strong interpersonal communication skills, high emotional intelligence, and be fluent in the art of negotiation.
This position will report into the Vice President, Commercial Manufacturing.
Key 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.
Required Skills & Experience:
- 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.
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 eligible for either remote or hybrid work arrangements.
Travel:
This position will require approximately 10-20% travel.
Compensation & 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 $225,000 - $250,000 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).
Culture & 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.
Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:
https://www.stoketherapeutics.com/careers/
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.
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