Our commitment to people with muscle diseases
is our greatest strength

Manager, Stability and Quality Control

Department: 110 CMC

Location: Waltham, MA

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary

The Manager, Stability and Quality Control (QC) 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 managing analytical development and QC activities in Phase 1 through BLA and commercial production. These activities will include coordinating external activities related to analytical method development and QC 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 including 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 remote role. Applicants must be able to relocate to the area.

Primary Responsibilities Include:

  • Responsibility for all aspects of developmental and GMP Stability management for intermediates, drug substances and drug products for all Dyne programs at CMOs and CROs
  • Provide 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
  • Establish and update tables of data for intermediates, drug substance and drug product for tracking and trending stability
  • Provide internal stability tracking and trending for drug substance and drug product using software appropriate to stability and expiry extension
  • Implement phase appropriate stability testing for starting materials, in-process control, DS and DP testing
  • Oversee 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
  • Oversee cross-functional laboratory investigations related to stability and laboratory operations
  • Collaborate with Quality management and CTOs to generate, review and approve documentation, including SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports
  • Responsibility for QC of CMC including analytical documents and CMC sections of regulatory submissions
  • Participate in preparation of responses to regulatory agency questions
  • Support QC testing in the lab as needed

Education and Skills Requirements:

  • A minimum of 3-5 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 required
  • 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
  • Experience and knowledge of data analysis and trending software is highly desirable.
  • Well versed with biologics and small molecules analytical development, quality control, and QA compliance of analytical methods
  • 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

#LI-Onsite

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.


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