{"id":1258120,"url":"https://alion.io/job/alnylam-associate-director-cmc-technology-delivery","title":"Associate Director, CMC Technology Delivery","company":{"id":1776651,"name":"Alnylam","domain":"alnylam.com","url":"https://alion.io/company/alnylam","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":100,"open_postings":3,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":17,"computed_at":"2026-10-21T05:46:15Z"}},"role":"Operations","role_family":"Operations","seniority":"head","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cambridge, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":172200,"max":233000,"currency":"USD","period":"year","gross":null,"usd_annual":233000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"AI Agents","optional":false},{"name":"Jira","optional":false},{"name":"Knowledge Graph","optional":false},{"name":"Python","optional":false},{"name":"Scrum","optional":false}],"status":"live","first_seen_at":"2026-09-09T20:48:31Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-21T04:58:07Z","board_verified":true,"closed_at":null,"days_open":41,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":41},"description":"Overview:\nAlnylam is seeking an experienced leader to serve as Associate Director, CMC Technology Delivery to lead the digital enablement and transformation of end-to-end Chemistry, Manufacturing and Controls (CMC). This role will execute digital strategy, drive innovation, strengthen compliance, and enhance operational performance to help Alnylam CMC scale with agility and deliver business outcomes. The position reports to the Sr. Director, CMC, Manufacturing and Supply Chain Technology within the Research & Early Development (ReDev) and Technical Operations & Quality (TOQ) Technology organization.\nAs a recognized subject matter expert, this leader will act as hands-on IT practitioner for the CMC organization enabling scalable, compliant, and efficient processes across starting material, drug substance and drug product process sciences, analytical sciences, CMC statistics and CMC program management from preclinical to clinical and commercial launch phase. This role will partner closely with the CMC business organization, IT software and service suppliers (e.g. Software-as-a-Service, system integrators), and internal IT teams-including Data/AI, Infrastructure Services, PMO to design, implement, and continuously improve CMC digital technology solutions across their full lifecycle\nHybrid role based in Cambridge, MA, with 3 days/week onsite.\nResponsibilities:\nDefine and execute the IT solutions roadmap aligned with business priorities and digital transformation goals for CMC organizations\nOversee the implementation and lifecycle management of digital CMC solutions that bring speed-to-market for new pipeline products from declaration of Development Candidate (DC) to regulatory filings for Investigational New Drug (IND) and New Drug Application (NDA) to commercial launch\nDrive implementation of digital and AI/ML capabilities that enable faster and efficient regulatory authoring, bring speed and reduce error rates through digital tech transfer of Drug Substance, Drug Product, analytical methods and data, and drive insights through access to data and analytical capabilities\nCollaborate with CMC and IT Data/AI teams to enable creation, transformation and storage of process recipe master and reference data, transactional data from lab runs, design of experiment (DOE) runs and batch execution runs, and derived data from processing of the results through statistical models and trending outputs\nDeploy digital capabilities that enable structuring and standardizing process recipe data for Critical Process Parameters, Critical Quality Attributes, In-Process Control parameters, Normal Operating Ranges, Proven Acceptable Ranges and allow recipe version management as the chemistry tech transfers from process development to process characterization through site characterization and Process Performance Qualifications (PPQs)\nPartner to develop data assets, AI/digital capabilities for CMC statistics for Process Development and Characterization, Process and Product Control strategy, implementing and supporting lifecycle management of trending tools\nEnable digital capabilities that support CMC Program Management ranging from efficient transfer of programs from R&D to CMC, program start up and advancement enablement, program status reporting\nPartner with CMC, external Contract Manufacturing Organization (CMO), Software and Services partners, and Internal IT organization to develop data products, process templates, procedures and seamless system integrations (API/EDI) to enable efficient exchange of process data\nProliferate user adoption of data, AI, digital and statistical analytics capabilities to accelerate use cases from research trending to Process Flow Descriptions (PFD) to regulatory specification filing, control strategy drafting, regulatory question responses to supporting commercial manufacturing for process control and monitoring, investigations and process optimization\nPartner with the IT Data/AI team and the CMC organization to establish process data governance, process data stewardship, and process data products on the enterprise data platform to enable analytics and AI/ML capabilities for CMC operations\nOwn end-to-end accountability for the lifecycle of CMC applications - from strategy and design through deployment, sustainment, upgrades, continuous improvement, and retirement. Partner with the business to define business case and articulate outcomes, manage total cost of ownership of digital solutions\nEnsure systems meet GxP, data integrity, and global regulatory requirements (e.g. FDA 21 CFR), maintaining audit readiness\nDrive operational excellence by ensuring reliability, performance, compliance, and high-quality support of CMC systems (e.g., Empower, SoftMax Pro, Emerson Process Knowledge Management, QbDVision)\nLead and mentor a team of cross-functional and IT resources. Oversee end-to-end delivery of initiatives and build strong partnerships with business stakeholders, IT teams, vendors, and procurement\nQualifications:\nBachelor’s degree in Science, Engineering, Information Technology or related field\n10+ years of experience in CMC, Process Engineering or IT client-facing roles for CMC and Process/Analytical Development organizations in biopharmaceuticals or life sciences industry\nExperience with some of the following: regulatory filing process, understanding of recipe unit operations and data structures, statistical software and analytical trending tools (e.g. multi-variate data analysis, assay and control charts, JMP, Minitab, R, Python, SIMCA batch-on line, SEEQ, etc.)\nExceptional stakeholder management and influencing skills with operations leaders and scientist user base. Change management and transformation leadership\nExperience with data and systems integration, analytics, working with system integrators and managing IT suppliers\nExperience in regulated environments (GxP, computer systems validation, FDA 21 CFR regulations)\nKnowledge of full System Development Life Cycle (SDLC) - requirements, design, implementation, integration and testing, release and deployment, operations & maintenance, decommissioning\nDemonstrated success building and leading cross-functional teams\nStrategic mindset with a pragmatic approach - balancing long-term vision with reliable delivery of measurable business outcomes\n10% travel maybe required\nPreferred\nMaster’s degree, MBA or PhD\nWorking knowledge of EDI, APIs, system integration and data transfers\nExperience with Agile & Scrum methodologies, leveraging Jira (or similar tools) for tracking projects risks, issues, tasks and user stories, and project management best practices.\nFamiliarity with emerging AI, data and digital capabilities (data models, data lakehouse architecture, knowledge graphs, agentic AI, LLMs)\nAbout Alnylam\nWe are the leader in RNAi therapeutics - a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.\nAt Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.\nBefore applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.\nThe pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).\nAlnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.\nLearn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers\nU.S. Pay Range\n$172,200—$233,000 USD","description_format":"text","description_chars":9356,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Rare Disease Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-25T19:36:08Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 36 · green card filings: 9","filings_12m":36,"filings_prev_12m":48,"green_card_filings_12m":9,"median_offered_wage_usd":157500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+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":18,"band":"cold","label":"Long shot","p_open":1,"p_active":0.524,"p_room":0.35,"age_days":41,"expected_fill_days":17,"reasons":["conf:0","velocity","win:tail"],"computed_at":"2026-10-21T05:46:15Z"},"pay":{"stated_usd_annual":233000,"is_top_pay":true},"html_url":"https://alion.io/job/alnylam-associate-director-cmc-technology-delivery","json_url":"https://alion.io/job/alnylam-associate-director-cmc-technology-delivery.json","meta":{"generated_at":"2026-10-21T07:30:54Z","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":10684,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-22T00:00:00Z"}},"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":1776651},"rest":"https://alion.io/mcp/rest/get_company?id=1776651"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Falnylam-associate-director-cmc-technology-delivery"},{"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%2Falnylam-associate-director-cmc-technology-delivery"},{"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%2Falnylam-associate-director-cmc-technology-delivery"},{"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/alnylam-associate-director-cmc-technology-delivery\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Falnylam-associate-director-cmc-technology-delivery"}]}