Director, Oligonucleotide Manufacturing
About The Position
The Director, Oligonucleotide Manufacturing, translates Dyne’s CMC and program strategy into integrated manufacturing plans for oligonucleotide payloads from late-stage clinical development through commercial launch. The 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 sets operational priorities, performance expectations, and risk-mitigation plans to support 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. The role is based onsite in Waltham, Massachusetts, with no remote option.
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.
- Experience translating program or CMC strategy into 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.
- Strong business and financial acumen, including forecasting, external manufacturing spend, resource planning, and investment tradeoffs.
- 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, including the ability to make and communicate recommendations on complex technical and business matters.
- Excellent verbal, written, and presentation skills; 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.
Nice To Haves
- Commercial launch experience.
Responsibilities
- Translate CMC and program strategy into 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 functional objectives, operational targets, and milestones.
- Select, qualify, and govern external CDMOs, setting expectations and accountability for quality, compliance, cost, service, and delivery.
- Ensure continuity of clinical and commercial supply through capacity planning, demand and supply alignment, scenario planning, and proactive risk mitigation.
- Develop forecasts, manage external manufacturing spend, evaluate investment options, and recommend cost, capacity, and sourcing tradeoffs.
- Lead technology transfer, scale-up, process validation, process improvements, and resolution of 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; support responses to health authority questions and inspections.
- Lead cross-functional decision-making 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, standards and processes, and coaching.
- Evaluate and implement emerging technologies and external capabilities to improve product quality, process performance, scalability, and cost effectiveness.
- Prepare and deliver technical documentation, governance updates, publications, and presentations for internal and external audiences.
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What This Job Offers
Job Type
Full-time
Career Level
Director
