Stoke Therapeutics

Director, CMC Lead

Bedford, Massachusetts, United States; Remote · Director

Sponsorship not specified$10k-$20kDetected 6 days ago

Product ManagementSupply ChainGMPFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingMentoring

About the role

About Stoke: Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine.
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).

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.
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.
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.
IND/IMPD, NDA/MAA, meeting briefing documents and other regulatory documents
Our values guide our work to deliver meaningful medicines for people who need them.

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.
Proven experience authoring and leading CMC sections of global regulatory submissions, including INDs/IMPDs, BLAs/MAAs/JNDAs, and post-approval filings.
Required Skills & Experience:

Bachelor's degree in biochemistry, chemical engineering, pharmaceutical sciences, or a related field required
advanced degree (MS or PhD) strongly preferred.

Minimum 5 years of leadership experience within a CMC function in biologics, oligonucleotides, or advanced therapeutics.
Proven track record of leading and aligning cross-functional technical teams in a matrixed organization.

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.

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.
In addition to base salary, Stoke offers an annual bonus and equity participation.

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.
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/
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.
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.

https://www.stoketherapeutics.com/careers/
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.

This listing is sourced directly from Stoke Therapeutics's careers page and normalized into a canonical job model.