Dyne Therapeutics is 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 deliver to muscle 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. For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
Director, Small Molecule CMC will be accountable for all small molecule development and manufacturing operations activities globally for our products. This role will partner closely with colleagues across Dyne to ensure seamless supply of all small molecule components for drug substance used in clinical trials and will lead efforts for commercial readiness. Experience with conjugatable linkers and ADCs is desirable.
This role is based in Waltham, MA without the possibility of being fully remote.
Primary Responsibilities Include:
- Lead small molecule development and manufacturing to support drug substance supply; collaborate with Supply, Quality Control, Quality Assurance, and Clinical Operations to esnusre continuity of drug supply
- Lead regulatory drafting, review and filing support for IND, BLA and other global dossiers.
- Act as main point of contact for CDMO(s) including leading CDMO working teams and strategic business review chairperson
- Responsible for driving execution of the production plan at CDMO (PO through delivery)
- Working with Procurement, Legal, and Strategic Sourcing take the lead in identification and resolution of business/contract issues and supply agreements
- Responsible for long term strategic supplier management and accountable for supplier relationship management
- Partners with Supply, Quality and Regulatory to champion a culture of quality with our CDMO's and to ensure that all activities and documentation comply with regulatory requirements
- Partner with Strategic Sourcing to develop and implement long term external manufacturing strategies that provide a reliable, robust, and cost-effective manufacturing network
- Champion a strong winning culture, fostering teamwork and commitment to excellent through transparent communication, engagement and collaboration
Education and Skills Requirements:
- Bachelor's Degree in Science or related field, or equivalent with 8-10 years of related work experience, or advanced degree and a minimum of 6 years of work experience
- Proven experience in clinical and commercial small molecule development and manufacturing as well as understanding of analytical techniques specially with chiral complex small molecules
- Demonstrated understanding of the principles and applications associated with external manufacturing operations
- Strong experience and knowledge of cGMP manufacturing requirements
- Strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
- Experience managing complex schedules and priorities in dynamic pharmaceutical, biotech or related environments.
- Experience in PPQ planning and activities
- Ability to work, influence, and gain consensus across multiple functions (CMC, Quality and Regulatory Affairs)
- Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, including IND, BLA, and post-approval changes
- Strong analytical, problem solving and critical thinking skills.
- Collaborative work style to be part of a team to identify process gaps and develop solutions
- Excellent interpersonal, verbal, and written communication skills with the ability to work in strong cross-functional relationships and communicate complex issues enterprise-wide, from the executive team to the manufacturing floor.
- Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors
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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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Dyne Therapeutics Waltham, Massachusetts, USA Office
1560 Trapelo Rd, Waltham, MA, United States, 02451
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