Director of Oligonucleotide Manufacturing & Strategy

BioSpace; Waltham (MA); Vor Ort; USD 200.000 - 240.000; Vollzeit

Zusammenfassung

Dyne Therapeutics in Waltham, MA is seeking a Director, Oligonucleotide Manufacturing to translate CMC strategy into scalable plans for late‑stage and commercial supply. The role leads external manufacturing, technology transfer, and governance across Research, Regulatory, Quality, Clinical, and Finance in a matrixed environment.

This position is based in Waltham, MA with no remote option, and requires extensive experience in oligonucleotide payloads, cGMP, and global regulatory submissions.

Qualifikationen

• 10+ years of progressive oligonucleotide manufacturing and CMC experience.
• Experience translating program strategy into manufacturing plans.
• Experience selecting and governing CDMOs with accountability for quality and supply.
• Experience leading technology transfer, scale‑up, and late‑stage manufacturing.
• Strong business and financial acumen with forecasting and spend management.
• Ability to lead cross‑functional work and influence without authority.
• Experience establishing governance and scalable processes.
• Knowledge of industry trends, regulatory requirements, and clinical manufacturing.
• Strong communication and leadership skills.

Aufgaben

• Translate CMC and program strategy into integrated oligonucleotide manufacturing plans, priorities, budgets, resource requirements, timelines, and risk‑mitigation actions.
• Lead oligonucleotide payload manufacturing from late‑stage clinical development through commercial launch.
• Select, qualify, and govern external CDMOs, establishing performance expectations and accountability for quality, cost, and delivery.
• Ensure uninterrupted clinical and commercial supply through long‑range capacity planning and risk mitigation.
• Provide financial stewardship for external manufacturing activities including forecasting and spend management.
• Lead technology transfer, scale‑up, process validation, and issue resolution across external partners.
• Review and approve cGMP documentation and related reports.
• Prepare and review CMC sections for global regulatory submissions and respond to health authority questions.
• Lead cross‑functional decision‑making to define compliant CMC strategies.
• Advise senior leadership on manufacturing strategy and tradeoffs.
• Build scalable internal CMC and manufacturing capabilities through coaching and standards.
• Evaluate emerging technologies to improve quality, performance, scalability and cost.
• Prepare and deliver technical documentation and governance updates for internal and external audiences.

Kenntnisse

Oligonucleotide manufacturing

CDMO management

Technology transfer

Process validation

Regulatory submissions

Forecasting & budgeting

Ausbildung

Advanced degree in Chemistry, Biochemistry, Chemical Engineering, or Pharmaceutical Sciences

Jobbeschreibung

Dyne Therapeutics in Waltham, MA is seeking a Director, Oligonucleotide Manufacturing to translate CMC strategy into scalable plans for late‑stage and commercial supply. The role leads external manufacturing, technology transfer, and governance across Research, Regulatory, Quality, Clinical, and Finance in a matrixed environment.

This position is based in Waltham, MA with no remote option, and requires extensive experience in oligonucleotide payloads, cGMP, and global regulatory submissions.