{"id":3027960,"url":"https://alion.io/job/kailera-associate-director-cmc-operations","title":"Associate Director, CMC Operations","company":{"id":678636,"name":"Kailera","domain":"kailera.com","url":"https://alion.io/company/kailera","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":155000,"max":190000,"currency":"USD","period":"year","gross":null,"usd_annual":190000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"Smartsheet","optional":false}],"status":"live","first_seen_at":"2026-10-19T21:37:59Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-10-26T09:48:13Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.\nWe are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\nWhat You’ll Do:\nReporting to the Vice President, Technical Operations Portfolio Management, the Associate Director, CMC Operations will drive the planning and execution of Kailera’s programs, spanning technical development, CDMO partnerships, technology transfers, clinical and commercial manufacturing, and preparation of regulatory submissions. In partnership with Technical Operations core team representatives, the individual will support cross-functional Technical Operations Program Teams, build and maintain integrated CMC timelines, and manage risks, dependencies, and decisions across Kailera’s multiple development programs. The Associate Director will also support the preparation, forecasting, and monitoring of departmental budgets.\nRequired location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).\nResponsibilities:\nLead planning and execution of CMC workstreams across multiple development programs, from technical development through regulatory submission and product approval\nBuild and maintain integrated CMC project plans and timelines in Smartsheet, aligning drug substance, drug product, analytical, packaging, and supply activities with clinical and regulatory milestones\nLead and/or facilitate cross-functional Technical Operations Program Teams: set agendas, drive decisions, track action items, risks, and issues to resolution\nCoordinate activities with CDMO partners, including technology transfers and manufacturing campaigns, tracking deliverables against contracted scope and timelines\nIdentify, assess, and mitigate project risks and critical-path dependencies, and develop contingency plans where needed\nCoordinate CMC contributions to regulatory submissions, tracking authoring, review, and approval timelines\nWork closely with Technical Operations team, Quality, Regulatory, Clinical Supply, and Finance colleagues to maintain highly efficient practices for pharmaceutical product development and budget management\nProactively communicate project status, key issues, and other critical topics in a timely manner to the appropriate management level and relevant project team members, including through dashboards and governance updates\nEnsure quality, scope, and timelines are met across all assigned projects, and keep team members updated on target dates and priorities\nSupport departmental budget planning, forecasting, and expense tracking in partnership with Finance\nDrive continuous improvement of CMC project management tools, templates, and processes\nRequired Qualifications:\n10+ years of experience in pharmaceutical drug development, including 5+ years in CMC project management or a related program management role\nWorking knowledge of CMC development, technology transfer, and clinical and/or commercial manufacturing, including experience managing work with CDMOs\nTrack record of success managing multiple projects or programs simultaneously\nAdvanced proficiency in Smartsheet, with experience building integrated timelines and dashboards\nExperience with project budgets, forecasting, and expense tracking\nExcellent communication, facilitation, and presentation skills, including with senior leadership\nProven track record of creativity, problem solving, and productivity, particularly when no or minimal precedent is in place\nDemonstrated successful experience working in interdisciplinary and cross-cultural teams\nPreferred Qualifications:\nPMP or equivalent project management certification\nExperience supporting late-stage development and marketing application submissions (e.g., NDA Module 3)\nEducation:\nBachelor’s degree in a scientific discipline preferred; advanced degree a plus\nSalary Range\n$155,000—$190,000 USD\nFor Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us.\nEQUAL EMPLOYMENT OPPORTUNITY INFORMATION: \nKailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\nE-Verify:\nKailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\n #LI-Hybrid","description_format":"text","description_chars":5885,"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","Flexible time off","Life insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-21T19:37:38Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":6,"expected_fill_days":50,"reasons":["conf:0","win:early"],"computed_at":"2026-10-26T05:57:25Z"},"pay":{"stated_usd_annual":190000,"is_top_pay":false},"html_url":"https://alion.io/job/kailera-associate-director-cmc-operations","json_url":"https://alion.io/job/kailera-associate-director-cmc-operations.json","meta":{"generated_at":"2026-10-26T13:04:16Z","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":18119,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":678636},"rest":"https://alion.io/mcp/rest/get_company?id=678636"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fkailera-associate-director-cmc-operations"},{"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%2Fkailera-associate-director-cmc-operations"},{"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%2Fkailera-associate-director-cmc-operations"},{"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/kailera-associate-director-cmc-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fkailera-associate-director-cmc-operations"}]}