Head, Oligonucleotide Manufacturing & CDMO Strategy

Dyne Therapeutics, Inc.; Waltham (MA); On-site; USD 200,000 - 240,000; Full time

Job summary

Dyne Therapeutics, Inc. seeks a Director of Oligonucleotide Manufacturing to translate CMC strategy into integrated plans for oligonucleotide payloads from late-stage clinical development through commercial launch.

You will lead external manufacturing strategy, selection of CDMOs, technology transfer, scale-up, and supply continuity in a matrixed organization based in Waltham, MA. The role requires an advanced degree with 10+ years in oligonucleotide manufacturing and CMC, strong leadership and

Qualifications

• Advanced degree in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline
• 10+ years of progressive experience in oligonucleotide manufacturing and CMC, including hands-on experience with oligonucleotide payloads, oligonucleotide-based therapeutics, and conjugates
• Demonstrated experience translating program or CMC strategy into functional manufacturing plans, priorities, budgets, timelines, and risk-mitigation actions
• Significant experience selecting, governing, and influencing CDMOs, with accountability for cGMP performance, quality, compliance, cost, and supply outcomes
• Experience leading technology transfer, scale-up, validation, and late-stage clinical manufacturing; commercial launch experience preferred
• Strong business and financial acumen, including experience with forecasting, external manufacturing spend, resource planning, and investment tradeoffs
• Demonstrated ability to lead complex cross-functional work, reconcile competing priorities, and influence decisions without direct authority
• Experience establishing governance, operating standards, and scalable processes and building capability through coaching, knowledge transfer, or team development
• Strong knowledge of pharmaceutical and biotechnology industry trends, product development and life cycle management, global regulatory requirements, and clinical-stage manufacturing
• Strong judgment, facilitation, negotiation, and problem-solving skills, with the ability to make and communicate recommendations on complex technical and business matters
• Excellent verbal, written, and presentation skills, including the ability to communicate effectively with senior leaders, cross-functional teams, regulators, contractors, and external partners
• Ability to operate independently, lead in a matrixed environment, and adapt priorities as business and program needs evolve

Responsibilities

• Translate CMC and program strategy into integrated oligonucleotide manufacturing plans, priorities, budgets, resource requirements, timelines, and risk-mitigation actions for late-stage clinical and commercial supply
• Lead oligonucleotide payload manufacturing from late-stage clinical development through commercial launch, setting and delivering against functional objectives, operational targets, and key milestones
• Select, qualify, and govern external CDMOs, establishing performance expectations, operating standards, escalation pathways, and accountability for quality, compliance, cost, service, and delivery
• Ensure uninterrupted clinical and commercial supply through long-range capacity planning, demand and supply alignment, scenario planning, and proactive mitigation of continuity risks
• Provide financial stewardship for external manufacturing activities by developing forecasts, managing spend, evaluating investment options, and recommending cost, capacity, and sourcing tradeoffs
• Lead technology transfer, scale-up, process validation, process improvements, and timely resolution of complex manufacturing issues across external partners
• Review and approve cGMP documentation, including technology transfer, process and analytical development and validation reports, qualification protocols and reports, validation master batch records, and campaign summary reports
• Prepare and review CMC sections for global regulatory submissions, including INDs, IMPDs, and BLAs, and support responses to health authority questions and inspections
• Lead cross-functional decision-making with Research, Regulatory, Quality, Clinical, Finance, and other stakeholders to define compliant, scientifically sound, and executable CMC strategies
• Advise senior leadership on manufacturing strategy, partner performance, supply risk, capacity, investment needs, and technical or business tradeoffs
• Build scalable internal CMC and manufacturing capabilities through resource planning, knowledge transfer, development of standards and processes, and coaching of employees and cross-functional partners
• Evaluate and implement emerging technologies and external capabilities that improve product quality, process performance, scalability, and cost effectiveness
• Prepare and deliver technical documentation, governance updates, publications, and presentations for internal and external audiences

Job description

Dyne Therapeutics, Inc. seeks a Director of Oligonucleotide Manufacturing to translate CMC strategy into integrated plans for oligonucleotide payloads from late-stage clinical development through commercial launch.

You will lead external manufacturing strategy, selection of CDMOs, technology transfer, scale-up, and supply continuity in a matrixed organization based in Waltham, MA. The role requires an advanced degree with 10+ years in oligonucleotide manufacturing and CMC, strong leadership and