Associate Director, Analytical Development

The posting, as Dyne Therapeutics wrote it

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

• Lead analytical development and quality control strategies for oligonucleotide and small-molecule intermediates from early clinical development through commercialization
• Serve as the analytical SME and strategic lead for internal and external activities related to analytical operations of linkers and oligonucleotide intermediates
• Responsibilities will include aspects of analytical development of drug substance intermediates including method development, validation, characterization, tech transfer, specifications, release, and stability testing
• Assist with developing the analytical/QC strategy for small molecules and oligonucleotides guided by ICH framework
• Develop, review, and approve method transfer/validation protocols and validation

[…]
o small molecules and oligonucleotides.

• Experience with monoclonal antibodies or ADCs (mab-conjugates) and relevant analytical techniques a plus
• Experience with impurity control strategy including novel approaches for impurity detection, impurity ID and characterization for oligonucleotides/ small molecules
• Experience with managing external vendors required
• Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, ideally including post-approval experience, international experience, and negotiation experience with regulatory authorities
• Strong knowledge of cGMP/ICH/FDA/EU regulations
• Ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods
• Excellent interpersonal, organizational, negotiation, and communication skills; a team member than can work collaboratively with colleagues across functions
• Ability to travel (up to ~10%)

#LI-Onsite
MA Pay Range
$160,000 — $200,000 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.

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.