Senior Director, Drug Product Manufacturing

Position Summary

The Senior Director, Drug Product Manufacturing will be accountable for all activities related to successful development and manufacturing operations and drug product related activities globally for our products. This role will partner closely with colleagues across Dyne to ensure seamless supply of all drug product for clinical trials and will lead efforts for drug product commercial readiness and launch. This role is based in Waltham, MA without the possibility of being fully remote.

Primary Responsibilities

• Act as the subject matter expert in drug product development including formulation, container closure and sterile fill finish manufacturing
• Act as main point of contact for CDMO(s) including leading CDMO working teams and strategic business review chairperson
• Responsible for tech transfer, scale-up and cGMP manufacturing of drug product including PPQs
• Responsible for ensuring uninterrupted drug product supply for clinical studies, commercial readiness and launch
• Key contributor to drug product sections of BLAs / NDAs / INDs / IMPDs
• Collaborate with CMC, Quality Control, Quality Assurance, and Clinical Operations to ensure continuity of drug supply
• Responsible for driving execution of the production plan at CDMO (PO through delivery)
• Working with CMC, Legal, and Strategic Sourcing take the lead in identification and resolution of business / contract issues and supply agreements
• Partners with CMC, Quality and Regulatory to champion a culture of quality with our CDMOs 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 excellence through transparent communication, engagement and collaboration

Education And Skills Requirements

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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