{"id":1258115,"url":"https://alion.io/job/alnylam-associate-director-cmc-team-lead","title":"Associate Director, CMC Team Lead","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":30,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Management","role_family":"Management","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":161500,"max":218500,"currency":"USD","period":"year","gross":null,"usd_annual":218500},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Antibody Engineering","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-14T17:54:11Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-11-05T01:18:11Z","board_verified":true,"closed_at":null,"days_open":51,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":51},"description":"Overview\nThe Associate Director, Downstream, Emerging Modalities, is expected to provide technical leadership for downstream development of novel modalities, with primary responsibility for antibody purification, and antibody-oligonucleotide conjugate (AOC) purification as well as lead program(s) with the goal to enable transition from preclinical stages to human Proof Of Concept transition by leading CMC team as necessary for the assigned program.\nThe candidate will design and advance robust, phase-appropriate downstream processes that support development readiness, Phase I execution, and effective transition into later-stage development. The individual will lead purification strategy across internal and external teams and work closely with Research, Process Sciences, Analytical Development, Formulation Development, Regulatory, Technical Operations, Quality, and CDMO partners to establish scalable, fit-for-purpose processes for emerging modalities. This role will also contribute to regulatory CMC activities through authorship and review of submission-ready technical content and by serving as a downstream subject matter expert for regulatory-facing discussions, as needed.\nIn addition to being CMC team lead for the program, the position will serve as the downstream functional lead for new modalities and is expected to bring strong scientific judgment, practical development experience, and the ability to translate technical complexity into clear development strategies, risks, and recommendations for cross-functional teams and senior leadership.\nThis role is intended for a technically strong downstream leader who can define purification strategy, make sound development tradeoffs, and guide programs from early development through Phase I with limited precedent and high ambiguity.\nThe individual will collaborate effectively to build and manage integrated development plans, support development readiness packages, help shape external partner and CDMO strategy for early-phase programs, and ensure programs have a credible, phase-appropriate path into early development and Phase I execution. This role is intended to reduce late-stage CMC surprises, strengthen planning for emerging modalities, and enable more structured and repeatable pathways for programs beyond core RNAi.\nThis position is onsite and will be primarily located in Cambridge, MA.\nKey Responsibilities\nLead downstream process development strategy for emerging modalities, with emphasis on antibody purification, Antibody Oligo Conjugation purification\nDesign and oversee phase-appropriate purification processes that are scalable, robust, and aligned with early clinical development needs.\nEstablish purification approaches for novel and non-platform molecules, including capture and polishing strategy, UF/DF, impurity clearance, yield optimization, and process robustness.\nPartner closely with the internal conjugation team to ensure downstream purification processes and control strategies are aligned with conjugated product attributes and program development needs.\nWork closely with Analytical Development to define control strategies, characterize process performance, and ensure appropriate linkage between process design and product quality.\nAddress purification challenges associated with complex and conjugated molecules, including removal of residual species, aggregates, unconjugated components, process-related impurities, and other modality-specific quality risks.\nProvide technical leadership for downstream activities at CDMOs, including process design, study oversight, data review, troubleshooting, process transfer, and support of GMP manufacturing campaigns.\nCollaborate with antibody development, formulation, analytical, regulatory, and operations teams to ensure an integrated and phase-appropriate CMC strategy through Phase I.\nAuthor and review downstream sections of technical reports and regulatory submission documents, including support for IND and other early clinical CMC filings.\nServe as the downstream technical SME in regulatory-facing discussions related to purification process design, control strategy, process characterization, comparability considerations, and manufacturing readiness.\nIdentify technical risks, development gaps, and scalability concerns early, and provide clear recommendations to support program progression and efficient handoff into later-stage development.\nBuild and standardize downstream development practices, technical frameworks, and lessons learned to improve repeatability across antibody- and conjugate-based modalities.\nQualifications\nAdvanced degree in life sciences, pharmaceutical sciences, chemical engineering, bioengineering, or related field.\nTechnical knowledge of new modalities and ability to have seamless conversation with internal and external stakeholders.\nRelevant industry experience in CMC, pharmaceutical development, technical operations, program leadership, or external development.\nProven experience acting as CMC team lead for biologics or complex/hybrid modalities.\nExcellent communication skills and solid experience working on cross-functional drug development teams.\nExperience managing complex timelines, dependencies, and external partners (CDMOs).\nStrong understanding of early-phase CMC development and modality-related development risk.\nAbility to evaluate CDMOs for early phase work and onboard partners rapidly\nExperience in working with emerging modalities such as Antibody Oligo Conjugates (AOCs), Peptide Oligo Conjugates (POCs), peptide, biologics or related platforms\nAbility to translate technical complexity into clear plans, risks & decisions for leadership\nExcellent communication, organizational, and influencing skills.\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$161,500—$218,500 USD","description_format":"text","description_chars":8318,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"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":"2026-10-29T16:27:21+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":31,"band":"fade","label":"Fading","p_open":1,"p_active":0.691,"p_room":0.45,"age_days":51,"expected_fill_days":30,"reasons":["conf:4","win:tail"],"computed_at":"2026-11-05T05:54:30Z"},"pay":{"stated_usd_annual":218500,"is_top_pay":true},"html_url":"https://alion.io/job/alnylam-associate-director-cmc-team-lead","json_url":"https://alion.io/job/alnylam-associate-director-cmc-team-lead.json","meta":{"generated_at":"2026-11-05T06:21:06Z","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":7911,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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-team-lead"},{"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-team-lead"},{"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-team-lead"},{"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-team-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Falnylam-associate-director-cmc-team-lead"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1258115}},{"tool":"search_jobs","arguments":{"company":"alnylam.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1258115},"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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