{"id":3031431,"url":"https://alion.io/job/dyne-therapeutics-associate-director-analytical-development","title":"Associate Director, Analytical Development","company":{"id":2628,"name":"Dyne Therapeutics","domain":"dyne-tx.com","url":"https://alion.io/company/dyne-therapeutics","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":87,"open_postings":3,"ghost_share":0,"stale_share":0.333,"repost_share":0,"time_to_fill_p50_days":89,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Waltham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":160000,"max":200000,"currency":"USD","period":"year","gross":null,"usd_annual":200000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Chromatography","optional":false},{"name":"GMP","optional":false},{"name":"HPLC","optional":false}],"status":"live","first_seen_at":"2026-10-20T13:34:15Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-11-01T00:13:33Z","board_verified":true,"closed_at":null,"days_open":11,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":11},"description":"Company Overview:\nDyne 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.\nRole Summary:\nThe 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.\nThe 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. \nWorking 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. \nThis 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.\nPrimary Responsibilities Include:\nLead analytical development and quality control strategies for oligonucleotide and small-molecule intermediates from early clinical development through commercialization \nServe as the analytical SME and strategic lead for internal and external activities related to analytical operations of linkers and oligonucleotide intermediates \nResponsibilities will include aspects of analytical development of drug substance intermediates including method development, validation, characterization, tech transfer, specifications, release, and stability testing \nAssist with developing the analytical/QC strategy for small molecules and oligonucleotides guided by ICH framework \nDevelop, review, and approve method transfer/validation protocols and validation approaches \nSupport establishment of critical quality attributes and phase-appropriate specifications \nAdvise and plan extended characterization of drug substance intermediates to expand product understanding \nPartner 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.) \nOversee Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate \nLead, author, approve, or provide strategic direction for CMC analytically focused documentation for biologic INDs and BLAs and support FDA and EMEA interactions \nWork 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 \nEducation and Skills Requirements:\nA minimum of 8 years in Analytical Development and/or Quality Control \nBachelor’s or master’s degree in biology, biochemistry, chemistry, or similar related field required \nKnowledge of a variety of analytical techniques including liquid and gas chromatography, NMR, Karl Fischer, CD, AEX, chiral separations, RP-HPLC, and mass spectroscopy \nStrong quality and analytical background with experience in general, compendial and product-specific analytical tools and practices pertinent to small molecules and oligonucleotides. \nExperience with monoclonal antibodies or ADCs (mab-conjugates) and relevant analytical techniques a plus \nExperience with impurity control strategy including novel approaches for impurity detection, impurity ID and characterization for oligonucleotides/ small molecules \nExperience with managing external vendors required \nExperience 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 \nStrong knowledge of cGMP/ICH/FDA/EU regulations \nAbility to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods \nExcellent interpersonal, organizational, negotiation, and communication skills; a team member than can work collaboratively with colleagues across functions \nAbility to travel (up to ~10%) \nMA Pay Range\n$160,000—$200,000 USD\nThe 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.\nThe 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.\nDyne 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.","description_format":"text","description_chars":6537,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-21T20:23:08Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 7","filings_12m":7,"filings_prev_12m":6,"green_card_filings_12m":0,"median_offered_wage_usd":207500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":10,"expected_fill_days":89,"reasons":["conf:3","win:early"],"computed_at":"2026-10-31T05:58:55Z"},"pay":{"stated_usd_annual":200000,"is_top_pay":false},"html_url":"https://alion.io/job/dyne-therapeutics-associate-director-analytical-development","json_url":"https://alion.io/job/dyne-therapeutics-associate-director-analytical-development.json","meta":{"generated_at":"2026-11-01T02:32:15Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":3820,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2628},"rest":"https://alion.io/mcp/rest/get_company?id=2628"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fdyne-therapeutics-associate-director-analytical-development"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fdyne-therapeutics-associate-director-analytical-development"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fdyne-therapeutics-associate-director-analytical-development"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/dyne-therapeutics-associate-director-analytical-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fdyne-therapeutics-associate-director-analytical-development"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3031431}},{"tool":"search_jobs","arguments":{"company":"dyne-tx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3031431},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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