What are the responsibilities and job description for the Senior Manager, Quality Control position at Stoke Therapeutics?
About Stoke:
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase – or stoke – protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing broad potential for our approach to help people with severe diseases.
We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.
Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Position Purpose:
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.
Key Responsibilities:
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in our Bedford, MA location.
Travel:
This position will require approximately 15% travel.
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 Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation:
At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
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/ or follow the company on Twitter at @StokeTx.
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.
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase – or stoke – protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing broad potential for our approach to help people with severe diseases.
We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.
Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Position Purpose:
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.
Key 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in our Bedford, MA location.
Travel:
This position will require approximately 15% travel.
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 Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation:
At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
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/ or follow the company on Twitter at @StokeTx.
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.
