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Director, CMC Biologics

Department: 110 CMC

Location: Waltham, MA

Company Overview:

Dyne Therapeutics is a clinical-stage muscle disease company focused on 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 has a broad portfolio of programs for serious muscle diseases, including candidates 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 Director, CMC- Biologics is responsible for building our internal CMC capability (antibody process & analytical development) and for the management of external specialist mAb CDMOs under cGMP.  Areas include biologics process and analytical development, drug substance and drug product from pre-IND through late-phase clinical studies. This role is responsible for the delivery of robust, scalable, and cost-effective manufacturing. This position 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 a remote role. Applicants must be able to relocate to the area.

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
  • Qualify and manage external contract development and manufacturing organizations
  • Oversee process and assay technology transfers and the process through supply to clinical sites
  • Drive continuous improvement opportunities, adapts to, and solves challenges and leads the timely resolution of issues
  • Evaluate emerging technologies/applications to improve our products and processes
  • Partner with internal cross functional teams and serve as the liaison to define suitable, compliant, and defendable CMC strategies
  • 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 Tech Transfer, process and analytical development reports, qualifications, validations MBRs, and campaign summary report
  • Oversee the implementation of process improvements at CDMOs

Education & Experience

  • Advanced degree and 7-10 + years of experience in Biochemistry, Chemical Engineering, Pharmaceutical Sciences or equivalent with a focus on complex biologics
  • Direct experience working with upstream and downstream biologics processes
  • Antibody experience preferred
  • Solid experience in a CMC/cGMP environment
  • Technical depth of knowledge in formulation and process and analytical development
  • Experience managing CDMOs and oversight of cGMP activities
  • Track record in identifying and implementing CMC strategies from concept phases (pre-IND) through clinical cGMP manufacturing for development candidates
  • 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.


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