--- title: 'Associate Director, Formulation and Drug Product Development at Dyne Therapeutics' canonical: 'https://feeny.ai/job/associate-director-formulation-and-drug-product-development-dyne-therapeutics-v7tq5qnartdw' type: 'job' last_seen: '2026-11-02' --- # Associate Director, Formulation and Drug Product Development at Dyne Therapeutics - **Company:** Dyne Therapeutics - **Location:** Waltham, MA - **Compensation:** $159k–$195k - **Posted:** 2026-04-03 - **Last confirmed live:** 2026-11-02 - **Apply:** https://job-boards.greenhouse.io/dynetherapeutics/jobs/5836813004 ## 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, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne’s bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability. This role will partner closely with colleagues in Research, Pharmaceutical Quality, and Manufacturing to define Dyne’s strategy for bringing best-in-class medicines to patients in need, including high-concentration formulations for subcutaneous administration and lyophilized drug products to ensure seamless supply of all drug products for clinical trials. This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week. Primary Responsibilities Include: - Act as the subject matter expert for drug product development within the Technical Development group, including formulation development, selection of container closure systems, and sterile fill finish clinical manufacturing. - Act as main point of contact for CDMO(s) for external formulation development activities, and liaise with the Research group to define, streamline and execute early-stage formulation development efforts. - Build and enhance internal capabilities for formulation development in the laboratory. - Responsible for development, tech transfer, and scale-up of drug product processes, and cGMP manufacturing of clinical grade drug product (Phase 1-3). - Key contributor to drug product sections of early-stage clinical filings (INDs/IMPDs/Health Canada). - Collaborate with Technical Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs to ensure continuity of drug supply for early clinical evaluation. - Responsible for driving execution of the formulation development plan at CDMO (PO through delivery). - Champion a strong winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration. Education and Skills Requirements: - PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience. - Proven experience in clinical drug product formulation development including liquid fill finish, lyophilization, subcutaneous formulations, and other injectables. - Expertise in sterile fill-finish early clinical manufacturing as well as understanding of analytical techniques that support manufacturing activities. - Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing. - Strong experience and knowledge of cGMP manufacturing requirements. - Strategic thinker with a sense of urgency to deliver quality results on time and in a highly ethical and professional manner. - Experience managing complex schedules and priorities in a dynamic biotech environment. - Ability to work, influence, and gain consensus across multiple functions (Technical Operations, Quality and Regulatory Affairs). - Collaborative work style to be part of a team to identify process gaps and constructively develop solutions. - Excellent interpersonal, verbal, and written communication skills with the ability to establish strong cross-functional relationships. - Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors. #LI-Onsite MA Pay Range $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. 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 - [Associate Director, Analytical Development](https://feeny.ai/job/associate-director-analytical-development-dyne-therapeutics-waltham-k8tnm780t8yk) — 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