Director, Drug Product External Manufacturing
Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.
- Company Address : 1560 Trapelo Rd, Waltham, Massachusetts 02451, US
About Dyne Therapeutics
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.
Job Description
The Director, Drug Product External Manufacturing will be accountable for all Drug Product External Manufacturing operations 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.
This role is based in Waltham, MA without the possibility of being fully remote.
Primary Responsibilities Include :
Collaborate with CMC, Quality Control, Quality Assurance, and Clinical Operations to ensure continuity of drug supply.Act as main point of contact for CDMO(s), including leading CDMO working teams and serving as strategic business review chairperson.Responsible for driving execution of the production plan at CDMO (PO through delivery).Work with CMC, Legal, and Strategic Sourcing to lead the identification and resolution of business / contract issues and supply agreements.Responsible for long-term strategic supplier management and accountable for supplier relationship management.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 :
Bachelor's Degree in Science, Supply Chain, Business 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 Drug Product manufacturing as well as understanding of analytical techniques that support manufacturing activities.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.Expertise in use of MS Excel, as well as demonstrated proficiencies in Smartsheet, Visio, ERP systems, and Power BI (or similar application).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.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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