Senior Director, Quality Control

Stoke Therapeutics•Bedford, MA

4d•$235,000 - $260,000•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 selectively restore natural protein levels. The company's lead candidate, zorevunersen, is in Phase 3 development for Dravet syndrome, and Stoke is also targeting other diseases caused by haploinsufficiency. Stoke is headquartered in Bedford, Massachusetts.

Requirements

BS/BA, MS or PhD in Analytical Sciences or other relevant discipline (i.e., chemistry, biology).
15+ years of progressive experience in QC spanning late-stage development and commercialization and with significant leadership responsibility.
Strong working knowledge of GMP, data integrity principles and ICH guidelines.
Demonstrated expertise in analytical method validation, lifecycle management, and control strategy development.
Experience with regulatory filing preparation and messaging across global jurisdictions.
Proven ability to set high standards for performance and accountability, ensuring clarity of expectations and outcomes.
Effective in conflict resolution/management and negotiation skills.
Excellent leadership skills with ability to influence, collaborate and communicate effectively in a cross-functional organization.

Nice To Haves

Expertise in analytical method lifecycle management.
Ability to successfully work with CMOs and CTLs.
Proven ability to build scalable, phase appropriate processes in a lean environment.
Strong working knowledge of relevant FDA, EU, ICH GMP guidelines and regulations for phase appropriate application for product development.
Demonstrated ability to think outside of the box with a pragmatic risk-based approach for product development and quality management.
Willingness to roll up their sleeves and directly contribute to the implementation of processes, technical aspects of development and resolution of issues as required.

Responsibilities

Establish and lead Stoke’s global QC strategy for all stages of product development, aligned with CMC.
Act as a QC subject matter expert and thought partner to senior leadership.
Establish and maintain a phase appropriate analytical control strategy to support clinical development, global regulatory filings, and commercialization.
Oversee the lifecycle management of analytical methods for oligonucleotide products, including method transfer, qualification, validation, optimization, stability testing, specification justification and maintenance, shelf-life management, reference standard management and remediation.
Lead the QC group responsible for routine GMP in-process, release, and stability testing, and establish the long-term quality control testing strategy for clinical and commercial programs.
Lead selection, governance, and performance management of CTLs, ensuring excellence with respect to technical support, compliance, and consistent delivery.
Partner with CMC, QA, Regulatory Affairs and Program Teams to ensure QC strategies support overall control strategy.
Provide leadership and technical input into CMC and analytical sections of regulatory submissions (IND, NDA, IMPD, MAA).
As a QC and analytical expert, support interactions with Health Authorities, Stoke Partners and CTLs.
Provide GMP compliance interpretation, consultation, training, and ensure data integrity for all QC activities.
Mature Stokes’s QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner.
Drive continuous improvement initiatives across Quality Control.
Support Stoke’s GMP inspection preparation program and mock PAI inspections at CTLs and CMOs as necessary.
Influence Stoke’s Quality culture.
Lead, mentor, and develop a small team of quality control professionals.