Associate Director, Oligonucleotide CMC & External Manufacturing - Dyne Therapeutics

Dyne Therapeutics is focused on 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 are designed to overcome limitations in delivery to muscle tissue 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.

Role Summary:

The Associate Director, Oligonucleotide CMC and External Manufacturing is responsible for building our internal CMC capability and for the management of external specialist Oligonucleotide CDMOs under cGMP.  Areas include oligonucleotide process drug substance from pre-IND through late-phase clinical studies, process validation, PPQ supervision and BLA sections authoring. This individual manages our external CDMO’s to ensure that all supply partners are in compliance with appropriate global regulatory standards. In addition, the position provides leadership defining the company’s overall CMC strategy within a matrixed environment.  

This role is based in Waltham, MA without the possibility of being fully remote.

Primary Responsibilities Include:

• Build internal CMC capability commensurate with the development stage of the company
• Provide leadership and oversight/execution of our key operational targets and milestones
• Select, qualify and manage external contract development and manufacturing organizations
• Drive continuous improvement opportunities, adapt to and solve challenges and lead the timely resolution of issues
• Evaluate and implement emerging technologies/applications to improve our products and processes
• Supervise PPQ activities 
• Prepare technical documentation, publications, and oral presentations
• Prepare and review relevant CMC and product related sections and documentation for global regulatory submission
• Review and approve documents related to cGMP operations, including validation reports, qualifications protocols and reports, campaign summary report, validation MBRs, protocols and reports
• Oversee the implementation of process improvements at CDMOs

Education and Skills Requirements:

• Advanced degree and 8 years of experience in Chemistry, Chemical Engineering, Pharmaceutical Sciences or equivalent
• Solid experience in a CMC/cGMP environment
• Experience managing CDMOs and oversight of cGMP activities
• Commercial launch experience preferred
• Strong project management and interpersonal skills
• Knowledge of pharmaceutical and biotech industry trends and issues
• Knowledge of product development and life cycle
• Knowledge of FDA regulations, regulatory requirements, and clinical methodology
• Strong facilitation skills and ability to influence and negotiate positive outcomes
• Excellent communication skills (verbal, written, presentation) and ability to communicate well with all stakeholders and teams 
• Able to work both independently and in a team-oriented, collaborative environment
• Ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
• Effective collaboration skills in an environment with cross functional teams, contractors, resources, and third-party vendors

#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.