Director, Oligonucleotide Manufacturing

Role Summary:

The Director, Oligonucleotide Manufacturing, is accountable for translating Dyne’s CMC and program strategy into integrated manufacturing plans for oligonucleotide payloads from late-stage clinical development through commercial launch. This role leads external manufacturing strategy and execution, including CDMO selection and governance, technology transfer, scale-up, capacity planning, supply continuity, and cost management. The Director establishes operational priorities, performance expectations, and risk-mitigation plans to deliver robust, scalable, compliant, and cost-effective manufacturing. Working across Research, Regulatory, Quality, Clinical, Finance, and other functions in a matrixed environment, the Director leads cross-functional decision-making, advises senior leadership on manufacturing strategy and investment tradeoffs, and strengthens Dyne’s internal CMC capabilities. 

This role is based in Waltham, MA without the possibility of being a remote role.  

Primary Responsibilities Include:

• 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 

Education and Skills Requirements:

• 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 

#LI-Onsite