Director, Oligonucleotide Manufacturing

Dyne Therapeutics•Waltham, MA

1d•Onsite

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. It 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. The position is based in Waltham, Massachusetts and is not remote.

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 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.
Strong business and financial acumen, including experience with 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, 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.

Nice To Haves

Commercial launch experience.

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.
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 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.