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 Twitter, LinkedIn and Facebook.
The Director, Drug Product Manufacturing will be responsible for the implementation of the CMC strategy for manufacturing sterile fill/finish for therapies and application to the execution of Dyne’s drug development programs. This role includes overseeing development and production activities at contract development and manufacturing organizations (CDMOs). This role will work in a cross-functional CMC team environment to plan, coordinate, and execute development strategies and ensure timely manufacturing to support clinical supply. In addition, the successful candidate will collaborate to study process parameters, perform scale-up studies and technology transfers, troubleshoot process related issues and contribute to root cause analysis for manufacturing deviations and investigations. This role will also ensure that sterile drug product development and clinical supply timelines are met and will contribute support to regulatory CMC filings.
This role is based in Waltham, MA without the possibility of being a remote role.
Key Responsibilities Include:
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.