Manager, Quality Control

Company Overview:

Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. 

Role Summary:

The Manager, Quality Control will support and oversee stability programs as well as QC testing and release of antibody drug conjugates and intermediates. This role will also contribute to the management of analytical development and QC activities in Phase 1 through BLA and commercial production. These activities include coordinating QC efforts and support of analytical activities with contract development and manufacturing organizations (CDMOs), contract test labs (CTLs), and other external suppliers.

This role will work closely with stakeholders within CMC and cross-functionally with Development, R&D, Regulatory, and Project Management on QC related activities to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts.

This role is based in Waltham, MA without the possibility of being a fully remote role.
 
Primary Responsibilities Include:

• Support aspects of developmental and GMP Stability management for intermediates, drug substances and drug products for all Dyne programs at CMOs and CROs
• Support aspects of quality systems including OOS/OOT investigations, quality investigation records, change controls, deviations, CAPAs, etc.
• Collaborate in the oversight of stability studies to external vendors for preclinical and Phase I - III CMC activities
• Coordinate stability pulls, manage sample shipments with help of logistics to and from storage and testing sites, monitor and review data received from external sites
• Support tracking and trending of stability tables of data for intermediates, drug substance and drug product
• Conduct raw data review of vendor generated QC reports as needed
• Assist in the oversight of reference standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate
• Participate in the development and revision of product specifications; provide scientific input and statistical analysis of results
• Contribute to cross-functional laboratory investigations related to stability and laboratory operations as needed
• Contribute to the drafting/revision of QC and CMC sections of regulatory submissions as needed
• Participate in preparation of responses to regulatory agency questions
• Support testing in the lab as needed (10-15%)

Education and Skills Requirements:

• A minimum of4-6 years’ experience in GMP QC testing and/or QC stability management
• Degree in biology, biochemistry, chemistry, or similar related field required
• Strong quality and analytical background with experience in general, compendial and product-specific analytical tools and practices pertinent to monoclonal antibodies, small molecules, and their Mab-conjugates
• Experience with managing QC external vendors preferred.
• Working knowledge of a variety of analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, GC, and mass spectroscopy
• Strong knowledge of cGMP/ICH/FDA/EU regulations a plus.
• Experience and knowledge of data analysis and trending software (SLIMStat) is highly desirable.
• Well versed with biologics and small molecules quality control and QA compliance of analytical methods/data
• Team member who can work collaboratively with colleagues across all functions
• Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources
• Ability to set clear goals and consistently delivers
• Flexible and creative problem-solving skills
• Logical thinker to develop and evaluates options, identifying pros and cons
• Ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods
• Excellent communication and interpersonal skills with success in working across organizational boundaries at all levels to bring together people of diverse backgrounds and skill sets to create, influence, and negotiate win-win solutions
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Excellent organizational skills

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The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.