Our commitment to people with muscle diseases
is our greatest strength

Senior Manager, Drug Product Manufacturing

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 Senior Manager, 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.

Key Responsibilities Include:

  • Manage clinical manufacturing activities at external laboratories and manufacturing facilities for a sterile drug product
  • Lead drug product development from pre-IND to late-stage manufacturing and validation
  • Responsible for managing delivery of clinical supplies, development of efficient and scalable manufacturing processes
  • Perform product/process validation when required; including designing procedures, overseeing batch sampling, and analyzing data
  • Coordinate testing of new drug products in a timely manner, and developing appropriate control strategies
  • Implement drug product process evaluation and manufacturing activities in accordance with documented work plans and/or cGMP requirements
  • Document preparation related to GMP operations as requested and appropriate
  • Oversee the implementation and/or technology transfer of drug product processes and process improvements into CMOs
  • Monitor deviations and process/operational changes; ensure appropriate technical and management visibility within Spero to these events and facilitate feedback and decisions to the CMOs
  • Work closely with broader CMC and program teams to ensure on time delivery of drug product
  • Work collaboratively and transparently with Quality Assurance to ensure a high-quality level of cGMP
  • Coordinate technology transfers to ensure effective information flow, timeline execution, issue resolution, and documentation for cross-functional teams

Education & Experience

  • BS/MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or comparable scientific degree with 5+ years of experience in the Biotech or Pharmaceutical industry focused on drug product development and manufacturing
  • Proven track record in developing and scaling up formulations for sterile fill/finish including lyophilized formulations from pre-IND through late stage development
  • Extensive hands-on experience in the development and clinical manufacturing environment towards the development of sterile drug product
  • Lyophilization development experience a preferred, but not required
  • Familiarity with a contract manufacturing environment with an in-depth knowledge of drug product unit operations, impact of process parameters, in-process characterization techniques, process development, and principles of cGMP is a plus
  • Experience as primary author of relevant sections of INDs
  • Established and demonstrated experience in using a wide variety of formulation concepts across multiple development programs to deliver to a project’s Target Product Profile; experience in formulation or process technologies to employ enabling formulation technologies or unique delivery systems is desirable
  • Hands-on, can-do individual with a collaborative personal style and the ability to work well in a fast-moving team/collaborative environment
  • Experience with aseptic processing, sterile manufacturing required
  • Experience in a CMC/cGMP environment
  • Experience with CDMOs and cGMP activities
  • Strong project management and interpersonal skills
  • 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
  • Ability to travel up to 10% of the time

 

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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