Associate Director, Analytical Development
Required skills
- oligonucleotides
- small molecules
- analytical development
- quality control
- method development
- method validation
- technology transfer
- specifications
- release testing
- stability programs
Nice to have
- monoclonal antibodies
- ADCs
- linker-conjugates
- extended characterization
- post-approval experience
- negotiation experience
Role summary
Dyne Therapeutics is seeking an Associate Director, Analytical Development, Oligonucleotides in Waltham, MA. This full-time, onsite role leads analytical development and quality control strategies for oligonucleotide and small-molecule intermediates across clinical development to commercialization. Responsibilities include method development, validation, technology transfer, specifications, release testing, stability programs, impurity control, and product characterization. The Associate Director will provide strategic and technical leadership, oversee external partners (CDMOs, contract labs), and serve as an analytical subject matter expert. The role requires a minimum of 8 years of experience in Analytical Development/Quality Control with a Bachelor's or Master's degree in a related science field. Strong knowledge of cGMP/ICH/FDA/EU regulations and experience with various analytical techniques are essential. Experience with monoclonal antibodies or ADCs is a plus.
Company Overview:
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
The Associate Director, Analytical Development, Oligonucleotides leads analytical development and supports quality control strategies for oligonucleotide and small-molecule intermediates across clinical development, registration, and commercialization. This role provides strategic and technical leadership for analytical method development, validation, technology transfer, specifications, release testing, stability programs, impurity control, and product characterization.
The Associate Director independently leads multiple analytical workstreams and makes decisions that influence program strategy, product quality, regulatory submissions, and clinical supply. The role provides oversight of CDMOs, contract testing laboratories, and other external partners to ensure analytical activities meet scientific, regulatory, quality, timeline, and business requirements.
Working closely with CMC, Quality, Regulatory Affairs, Supply Chain, Research and Development, Clinical, and Project Management, this position establishes analytical priorities, resolves complex technical issues, manages program risks, and guides cross-functional decision-making. The Associate Director also serves as an analytical subject matter expert, mentors colleagues, and strengthens analytical capabilities and practices across the organization.
This is a full-time position based in Waltham, MA without the possibility of being remote. Physical presence onsite is expected on 4-5 days/week.
Primary Responsibilities Include:
Education and Skills Requirements:
#LI-Onsite
MA Pay Range$160,000—$200,000 USDThe 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.
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. 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.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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