--- title: 'Associate Director, Analytical Development at Dyne Therapeutics' canonical: 'https://feeny.ai/job/associate-director-analytical-development-dyne-therapeutics-waltham-k8tnm780t8yk' type: 'job' last_seen: '2026-11-02' --- # Associate Director, Analytical Development at Dyne Therapeutics - **Company:** Dyne Therapeutics - **Location:** Waltham, MA - **Compensation:** $160k–$200k - **Posted:** 2026-10-20 - **Last confirmed live:** 2026-11-02 - **Apply:** https://job-boards.greenhouse.io/dynetherapeutics/jobs/6225554004 ## Job description 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. 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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 approaches - Support establishment of critical quality attributes and phase-appropriate specifications - Advise and plan extended characterization of drug substance intermediates to expand product understanding - Partner with QC and QA to provide oversight of cGMP activities and documents (change controls, deviations, CAPAs, procedures, QC raw data review, batch release support, stability protocols and programs, validation protocols, etc.) - Oversee Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate - Lead, author, approve, or provide strategic direction for CMC analytically focused documentation for biologic INDs and BLAs and support FDA and EMEA interactions - Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target timeframes Education and Skills Requirements: - A minimum of 8 years in Analytical Development and/or Quality Control - Bachelor’s or master’s degree in biology, biochemistry, chemistry, or similar related field required - Knowledge of a variety of analytical techniques including liquid and gas chromatography, NMR, Karl Fischer, CD, AEX, chiral separations, RP-HPLC, and mass spectroscopy - Strong quality and analytical background with experience in general, compendial and product-specific analytical tools and practices pertinent to 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. ## About Dyne Therapeutics ## Company Overview - **One-liner**: Dyne Therapeutics is a clinical-stage biotechnology company developing targeted nucleic acid therapies for genetically driven neuromuscular diseases using its proprietary FORCE™ platform. - **Entity Type**: Public (NASDAQ: DYN) - **Headquarters**: Waltham, Massachusetts, United States - **Founded**: 2018 - **Founders**: Not publicly available (the company was co-founded by a team of scientists and entrepreneurs; individual names not surfaced in search results) ## Core Business - **Primary industry**: Biotechnology / Biopharmaceuticals – rare neuromuscular disease therapeutics - **Target customers**: B2B / B2G – regulatory agencies, healthcare providers, payers, and most importantly patients with Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), facioscapulohumeral muscular dystrophy (FSHD), and Pompe disease. - **Mission / Purpose**: “Delivering functional improvement for people living with neuromuscular diseases.” [dyne-tx.com](https://www.dyne-tx.com/) ## Products & Services Dyne’s pipeline is built around its FORCE™ platform, which uses an antigen-binding fragment (Fab) conjugated to transferrin receptor 1 (TfR1) to deliver therapeutic payloads to muscle and the central nervous system. - **Z‑rostudirsen (DYNE‑251)** – An investigational therapeutic for DMD patients amenable to exon 51 skipping. Consists of a phosphorodiamidate morpholino oligomer (PMO) conjugated to an anti‑TfR1 Fab. Phase 1/2 DELIVER trial met primary endpoint; BLA submission for U.S. Accelerated Approval planned for Q2 2026 with potential launch in Q1 2027. [investors.dyne-tx.com](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025) - **Z‑basivarsen (DYNE‑101)** – Investigational therapeutic for DM1, using an antisense oligonucleotide (ASO) conjugated to anti‑TfR1 Fab. Phase 1/2 ACHIEVE trial fully enrolled; Phase 3 HARMONIA trial ongoing. [dyne-tx.com](https://www.dyne-tx.com/pipeline/) - **DYNE‑302** – Preclinical candidate for FSHD, using an siRNA payload to suppress DUX4 expression. [dyne-tx.com](https://www.dyne-tx.com/pipeline/) - **DMD Franchise Expansion** – Four additional development candidates (DYNE‑253, DYNE‑245, DYNE‑244, DYNE‑255) targeting exons 53, 45, 44, and 55 for DMD, entering IND‑enabling studies. [investors.dyne-tx.com](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025) ## Market Standing - **Valuation / Market Cap**: Not disclosed in search results (public company; market cap fluctuates with stock price; current figure not provided in the sources). - **Key Metric**: Cash, cash equivalents and marketable securities of **$1.1 billion** as of December 31, 2025, providing runway into Q1 2028. [investors.dyne-tx.com](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025) - **Notable Investors / Partners**: Not listed in provided search results (likely institutional investors; prior venture rounds not detailed here). - **Growth Signals**: - Headcount grew **38.2% YoY** to **227 employees** (2025). [linkedin.com](https://www.linkedin.com/company/dynetx) - Positive topline results from DELIVER trial for z‑rostudirsen; potential first product launch in Q1 2027 if approved. - Advancing five distinct clinical/preclinical programs across multiple neuromuscular indications. ## Competitive Advantages - **FORCE™ Platform**: Differentiated delivery technology that uses a TfR1‑binding Fab to enable broad and deep tissue penetration in both muscle and CNS – addressing one of the biggest hurdles in neuromuscular drug development. - **Best‑in‑Class Potential**: Clinical data for z‑rostudirsen showed statistically significant dystrophin expression (5.46% of normal at 6 months, 7‑fold change) and preservation of lung function (FVC%p) compared to placebo, despite a small trial not powered for functional endpoints. - **Broad Pipeline**: Covering multiple exon‑skipping opportunities in DMD as well as entirely different diseases (DM1, FSHD, Pompe) with the same core platform, reducing risk and enabling rapid expansion. ## Strategic Focus - **Regulatory Submission**: File a Biologics License Application (BLA) for z‑rostudirsen in Q2 2026 under U.S. Accelerated Approval pathway. - **Late‑Stage Trials**: Initiate two field‑defining Phase 3 confirmatory trials (FORZETTO for DMD and HARMONIA for DM1) in 2026 following FDA alignment on design. - **Pipeline Expansion**: Move four additional DMD exon‑skipping candidates into IND‑enabling studies and advance preclinical DYNE‑302 (FSHD) toward the clinic. - **Commercial Readiness**: Prepare for potential first‑ever company launch in Q1 2027 with a focus on U.S. market, while also pursuing ex‑U.S. approval pathways. ## Why Work Here - **Mission‑Driven Culture**: The company’s “One Dyne community” ethos emphasizes accountability, transparency, fearlessness, and a relentless drive to deliver functional improvement for patients and families. [dyne-tx.com](https://www.dyne-tx.com/careers-culture/) - **Competitive Benefits**: Medical, dental, vision, 401(k), flexible vacation, paid holidays including a year‑end office closure, short‑ & long‑term disability, HSA/FSA accounts. [dyne-tx.com](https://www.dyne-tx.com/careers-culture/) - **Work Environment**: Office location in Waltham, MA (Boston area). Remote/hybrid policy not specified in search results; likely on‑site or hybrid for lab‑based roles. Career page lists roles such as Associate Director, Oligonucleotide Development; Scientist, RNA; Director of Training – reflecting a mix of research, clinical, and corporate functions. [job-boards.greenhouse.io](https://job-boards.greenhouse.io/dynetherapeutics) - **Growth Opportunity**: Joining a late‑stage biotech with a validated platform, strong cash position, and a clear path to commercialization – offering employees exposure to both R&D and upcoming launch activities. - **Recruitment Scam Warning**: Dyne posts an explicit notice on its careers page that it never requests financial details or payment during hiring; all legitimate emails come from @dyne‑tx.com addresses. ## Sources 1. [dyne-tx.com – Company Overview](https://www.dyne-tx.com/) 2. [dyne-tx.com – Careers & Culture](https://www.dyne-tx.com/careers-culture/) 3. [dyne-tx.com – Pipeline](https://www.dyne-tx.com/pipeline/) 4. [investors.dyne-tx.com – Q4/Full Year 2025 Results](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025) 5. [linkedin.com – Dyne Therapeutics Company Profile](https://www.linkedin.com/company/dynetx) 6. [job-boards.greenhouse.io – Dyne Careers Page](https://job-boards.greenhouse.io/dynetherapeutics) ## Other roles at Dyne Therapeutics - [Senior Research Associate, Histology & Microscopy](https://feeny.ai/job/senior-research-associate-histology-microscopy-dyne-therapeutics-waltham-z7ypgr0zc049) — Waltham, MA - [Senior Director, Sponsor Oversight and Monitoring Effectiveness](https://feeny.ai/job/senior-director-sponsor-oversight-and-monitoring-effectiveness-dyne-xgtf2wewr294) — Waltham, MA - [Director, Oligonucleotide Manufacturing](https://feeny.ai/job/director-oligonucleotide-manufacturing-dyne-therapeutics-waltham-0bgz63bxkahb) — Waltham, MA - [Director, Government Pricing & Contract Operations](https://feeny.ai/job/director-government-pricing-contract-operations-dyne-therapeutics-waltham-jk69cejw4737) — Waltham, MA - [Senior Director, Medical Affairs Biostatistics](https://feeny.ai/job/senior-director-medical-affairs-biostatistics-dyne-therapeutics-waltham-2f5wq33kjtjp) — Waltham, MA - [Director, Cost Accounting](https://feeny.ai/job/director-cost-accounting-dyne-therapeutics-waltham-k8qpf11tf80c) — Waltham, MA - [Director, Revenue](https://feeny.ai/job/director-revenue-dyne-therapeutics-waltham-t62v02kw61st) — Waltham, MA - [Associate Director, Market Research & Competitive Intelligence](https://feeny.ai/job/associate-director-market-research-competitive-intelligence-dyne-therapeutics-qc47ze0xw76k) — Waltham, MA - [Associate Director, Medical Information and Review](https://feeny.ai/job/associate-director-medical-information-and-review-dyne-therapeutics-waltham-ff9hs10jh3sd) — Waltham, MA - [Senior Administrative Assistant - US Affiliate](https://feeny.ai/job/senior-administrative-assistant-us-affiliate-dyne-therapeutics-waltham-y3emed522zqq) — Waltham, MA