Dyne Therapeutics
Associate Director, Oligonucleotide Development
Waltham, MA · Director
Sponsorship not specified$159k-$195kDetected 6 days ago
Project ManagementGMPFDA RegulatoryAnimal StudiesLeadershipCommunicationProblem SolvingPublic Speaking
About the role
- Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.
- The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
- Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Responsibilities
- Lead the design, optimization, and execution of process development for PMO and ASO payload molecules, ensuring scalability for clinical and commercial supply.
- Strong project management skills, with the ability to independently drive complex CMC programs to completion within aggressive timelines.
- Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Requirements
- PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience.
- Oligonucleotide Expertise: Proven track record in the process chemistry and development of PMO and ASO oligonucleotides, including deep technical knowledge of synthesis and purification.
- External Management: Direct experience in the selection, qualification, and oversight of CDMOs, including managing technology transfers and cGMP manufacturing campaigns.
- Regulatory Authority: Expert knowledge of FDA, EMA, and ICH guidelines with a successful track record of authoring and reviewing Module 3 sections for global regulatory submissions (IND, IMPD, etc.).
- Analytical Depth: Technical proficiency in analytical development, including impurity control strategies and physicochemical characterization of payload and conjugated drug substances.
- Strategic Problem Solving: Ability to navigate shifting priorities and evolving timelines using robust analytical and risk-mitigation capabilities.
- Proven track record in the process chemistry and development of PMO and ASO oligonucleotides, including deep technical knowledge of synthesis and purification.
- Direct experience in the selection, qualification, and oversight of CDMOs, including managing technology transfers and cGMP manufacturing campaigns.
- Expert knowledge of FDA, EMA, and ICH guidelines with a successful track record of authoring and reviewing Module 3 sections for global regulatory submissions (IND, IMPD, etc.).
- Technical proficiency in analytical development, including impurity control strategies and physicochemical characterization of payload and conjugated drug substances.
Compensation
- $159,000 - $195,000 USD
- The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting.
- Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.
Benefits
- Set the vision for analytical development, focusing on robust impurity control strategies, raw material specifications, and comprehensive physicochemical characterization for both payloads and conjugated drug substances.
Company info
- We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease.
- At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
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