Senior Manager, Quality Control

Stoke Therapeutics•Bedford, MA

4d•$172,000 - $192,000•Hybrid

About The Position

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/ 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.

Requirements

B.S. in Biochemistry, Chemistry, Biology, Pharmaceuticals or equivalent with a minimum of 8+ years’ combined experience in biopharmaceutical product development including Analytical Method Development, qualification / validation and transfer of methods to CTL’s.
Minimum of 3+ years of experience in analytical method development and validation for devise including pre-filled syringes
Fully versed in GMPs, ICH Guidelines, FDA, and other regulatory agency requirements related to laboratory functions.
Operational QC experience with experience providing Quality support and oversight of GMP laboratory operations at CTLs / CMOs for product release testing.
Attention to detail with the ability to work within a multi-disciplinary team, as well as with external partners and vendors to establish and maintain a strong quality relationship.
Familiar with the use of electronic document management, laboratory information management and statistical analysis techniques.
Ability to work autonomously, provide QC advice, effectively manage time, and deliver results on time.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

Nice To Haves

Advanced Degree in Science (M.S. or Ph.D.)
Strong experience with GMP laboratory management with specific experience in writing regulatory submissions (IND, IMPD, NDA, MAA) and supporting regulatory inspections.
Hand-on experience for analytical methods used for pre-filled syringes
Strong verbal and written communication skills.
Ability to manage multiple projects in a fast-paced environment.
Excellent organizational, interpersonal, verbal, and written communication skills.
Conflict resolution/management and negotiation skills.

Responsibilities

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 medical devices for release and stability
Use scientific expertise to aid CMC in troubleshooting analytical compliance issues and resolution.
Provide QC oversight for method transfers, method qualification and validation.
Review and approve analytical documentation generated at CTLs / CMOs, including specifications, analytical method validation protocols/reports and CoAs.
Evaluate data to detect product or method-related trends. Write periodic trend summaries.
Contribute to the preparation and review of analytical sections of CMC for regulatory submissions and annual reports.
Review and approve laboratory investigations related to release and stability testing performed on GMP samples. Ensure that records and technical data are accurately maintained and results well documented.
Support the product stability program, including compliance with policies and practices for stability protocol execution; review of stability data; review for potential trends to ensure compliance with regulations.
Represent QA / QC on project teams, as needed and provide GMP compliance interpretation, consultation, and other supportive services necessary to maintain and improve compliance to ensure product quality, data integrity and patient safety.
Assist audits of laboratories, as necessary, and work with Stoke staff to ensure the implementation of appropriate CAPAs.
Provide GMP compliance technical support during regulatory inspections at Stoke’s CTLs / CMOs as necessary
Provide input to and review of responses to regulatory agency questions resulting from regulatory inspections.
Contribute to the development of Stoke’s Quality culture.