Senior Manager, Quality Control

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

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

The Sr. Manager, Quality Control (QC) is responsible for overseeing all aspects of GMP testing and supporting stability program management for Stoke’ IMPs at Stoke’s Contract Testing Laboratories (CTLs) / Contract Manufacturing Organizations (CMOs). In this role, this person is accountable for ensuring that Stoke’s product stability programs are successfully designed, implemented and executed at CTLs to support product shelf-life for clinical use.

This individual will also lead stability transfers of products including sample chain of custody for both stability and routinely manufactured products, sample management, protocol design, implementation, analysis, reporting, and trending. This person will support Stoke’s CMC team with analytical method transfers and validation to and at Stoke CTLs / CMOs. This person will also be a key contributor to maturing and shaping Stoke’s internal GMP quality processes for QC laboratory controls and is responsible for supporting Stoke’s CMC Manufacturing and Analytical Development teams towards ensuring compliance with regulations (e.g., FDA, EMA, etc.).

The Sr. Manager, QC is accountable for regulatory inspection interactions related to analytical method validation and product testing. This individual will oversee the deployment of strategy for analytical method development / transfer and validation for Stoke’s products, specifications development as well as QC for GMP testing across Stoke’s CTL / CMO network. Other functions for this role include oversight of laboratory investigations related to product testing;

review and approval of test results, annual reports, and technical reports; and authoring and review of CMC analytical sections of regulatory submissions.

• Establish and maintain QC SOPs for GMP testing, laboratory controls, analytical method qualification /validation, reference standard management and stability management to meet ICH, FDA, and EMA regulations.
• Oversee day-to-day management of outsourced GMP release testing at various CTLs / CMOs to ensure successful and compliant execution of laboratory operations to meet GMPs, regulatory requirements, guidelines, internal policies, and procedures.
• Evaluate the sample size requirement for functional testing of…