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 position will be responsible for product development, technology transfer and overall management of CMC activities related to the antibody ensuring robust development and reliable GMP supply of antibody drug conjugates and intermediates. Depending on the product phase, the Senior Director provides both guidance and active management of antibody in Phase 1 thru BLA and commercial production. This will include coordinating external development and manufacturing with contract development and manufacturing organizations (CDMOs), contract test labs (CTLs) and other external suppliers. Another primary responsibility will the management of the clinical supply chain which includes integrated project management of all CMC vendors, shipping international and domestic, storage and clinical distribution, and management of drug product activities for clinical supply/ S/he will also have a matrix role for research and development activities related to antibody, bioconjugation and small molecule manufacturing.
This management role will report to the VP, CMC and will work closely with key stakeholders including Development, R&D, Clinical, Regulatory Affairs, Project Management, and corporate leadership to define and build the capabilities required to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts.
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.