{"id":390411,"url":"https://alion.io/job/moderna-inc-director-cmc-stability","title":"Director, CMC Stability","company":{"id":5847,"name":"Moderna","domain":"modernatx.com","url":"https://alion.io/company/modernatx","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":90,"open_postings":12,"ghost_share":0,"stale_share":0.417,"repost_share":0,"time_to_fill_p50_days":55,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Operations","role_family":"Operations","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":["Norwood, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":167000,"max":300700,"currency":"USD","period":"year","gross":null,"usd_annual":300700},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[],"status":"live","first_seen_at":"2026-07-24T00:00:00Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-11-05T10:22:15Z","board_verified":true,"closed_at":null,"days_open":104,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":104},"description":"The Role\nCMC is seeking a dynamic and experienced Director, CMC Stability to lead an end-to-end stability function spanning non-clinical-enabling, clinical, and commercial programs. This leader will translate target product profile (TPP) expectations into scientifically robust stability and shelf-life strategies, design stability studies that demonstrate those claims, and ensure stability data are generated, interpreted, and communicated in ways that enable timely CMC decisions, regulatory filings, and product lifecycle management. This is an onsite role based in Moderna’s Technology Center campus in Norwood, MA.\nIn this role, you will lead a high-performing stability team responsible for portfolio stability strategy, study design, capacity planning, data trending and expiry assessment, stability reviews, stability forecasting, submission authoring, and responses to health authority questions. You will be accountable for ensuring stability strategy is integrated into product team milestones and that program teams have clear, decision-grade stability updates at the moments that matter.\nTo be successful, you will bring strong CMC judgment, deep stability science, and the ability to make practical trade-off decisions in a fast-paced, matrixed environment. You will help teams evaluate deviations, excursions, out-of-trend signals, capacity constraints, shelf-life optionality, and prioritization decisions with clear understanding of compliance, supply, patient, and regulatory implications. You are an execution-oriented leader who can establish effective operating models, develop talent, and influence across Analytical Development, Quality, Regulatory CMC, Manufacturing, MS&T, Clinical Supply, Commercial Supply, and product teams.\nHere’s What You’ll Do\nLead the end-to-end CMC Stability function across non-clinical-enabling, clinical, and commercial programs, ensuring stability strategies are aligned with product goals, CMC strategy, regulatory expectations, and supply needs.\n\nTranslate target product profile (TPP) expectations into required stability and shelf-life claims, including storage condition, in-use, shipping, handling, excursion, and lifecycle flexibility needs.\n\nDefine and oversee scientifically robust stability study designs that demonstrate claims are met and support clinical advancement, regulatory approvals, commercial launch, and post-approval lifecycle management.\n\nBuild and maintain effective stability operating models, governance, and decision forums that clarify product team accountability, critical milestones, stability deliverables, and escalation pathways.\n\nDrive effective utilization of stability capacity to enable shelf-life flexibility, regulatory optionality, lifecycle commitments, comparability assessments, and strategic portfolio prioritization.\n\nIn partnership with Quantitative Sciences, oversee stability data trending, statistical analysis, expiry assessments, and stability reviews to identify emerging risks, inform shelf-life decisions, and enable clear cross-functional action plans.\n\nProvide technical leadership for out-of-trend investigations, atypical stability observations, temperature excursions, shipping excursions, deviations, comparability questions, and product risk assessments.\n\nMake and influence risk-based decisions on prioritization and trade-offs across stability studies, sample pulls, testing capacity, data package timing, regulatory commitments, and supply continuity.\n\nPartner with Quantitative Sciences, Analytical Development, Quality Control, Quality Assurance, Regulatory CMC, Manufacturing, MS&T, Clinical Supply, Commercial Supply, and program teams to ensure stability plans are executable and integrated with broader CMC control strategies.\n\nOversee authoring and review of stability sections for regulatory submissions, briefing packages, annual reports, post-approval supplements, and responses to health authority questions, including relevant RTQs.\n\nEstablish portfolio-level stability forecasting, dashboards, and metrics, including study start readiness, pull/test cadence, turnaround time, backlog, protocol/report cycle time, and regulatory commitment tracking.\n\nDevelop, mentor, and lead a high-performing team of stability leads and associates, fostering a culture of scientific rigor, accountability, compliance, collaboration, and continuous improvement.\n\nHere’s What You’ll Need (Basic Qualifications)\nEducation: Degree in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or related technical discipline\n\nExperience: 15 years of relevant experience with Bachelor’s degree or 10 years of relevant experience with a PhD\n\nHere’s What You’ll Bring to the Table (Preferred Qualifications)\nPhD in a relevant scientific or engineering discipline is preferred.\n\nDeep expertise in stability strategy and execution across development, registration, commercial launch, and lifecycle management for biologics, vaccines, mRNA/nucleic acid-based therapeutics, drug products, or other complex modalities.\n\nStrong knowledge of global stability expectations and guidance, including ICH Q1A-Q1E, accelerated and long-term stability design, statistical shelf-life assessment, bracketing/matrixing concepts, and post-approval stability commitments.\n\nDemonstrated ability to translate product, patient, supply, and regulatory needs into executable stability strategies, shelf-life claims, storage conditions, and risk-based evidence packages.\n\nExperience authoring or contributing to IND/CTA/BLA/MAA stability sections, health authority responses, RTQs, annual reports, post-approval supplements, and regulatory commitment management.\n\nStrong technical judgment in stability data interpretation, trend analysis, expiry assignment, out-of-trend investigations, temperature excursions, deviations, comparability assessments, and product risk management.\n\nExperience developing and operationalizing stability workflows, governance models, dashboards, capacity forecasts, and metrics that improve transparency, prioritization, cycle time, quality, and decision-making.\n\nProven track record leading cross-functional teams and influencing stakeholders across Analytical Development, QC, QA, Regulatory CMC, Manufacturing, MS&T, Clinical Supply, Commercial Supply, and product teams.\n\nStrong people leadership experience, including hiring, developing, coaching, and performance management of technical staff in a matrixed environment.\n\nExcellent communication, executive presence, and stakeholder management skills, with the ability to communicate complex stability risks and trade-offs clearly to technical and non-technical audiences.\n\nAbility to operate strategically while driving detailed execution in a fast-paced environment, with a commitment to scientific rigor, compliance, continuous improvement, and Moderna’s values of Bold, Relentless, Curious, and Collaborative.\n\nPay & Benefits\nAt Moderna, we believe that when you feel your best, you can do your best work.That’s why our benefits and well-being resources are designed to support you-at work, at home, and everywhere in between.\nCompetitive healthcare, plus voluntary benefit programs to support your unique needs\nA holistic approach to well-being, with access to fitness, mindfulness, and mental health support\nFamily planning benefits, including fertility, adoption, and surrogacy support\nGenerous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown\nSavings and investments to help you plan for the future\nLocation-specific perks and extras\nThe salary range for this role is $167,000.00 - $300,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.\n\nThe successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.\nAbout Moderna\nSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.\nBy living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.\nWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.\nIf you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.\nEqual Opportunities\nModerna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!\nModerna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.\nAccommodations\nWe’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.\nModerna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at .\nExport Control Notice\nThis position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.\n\n-","description_format":"text","description_chars":11239,"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":["Prescription Drugs","Vaccines","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-05T23:10:17Z"},{"event":"close","at":"2026-09-30T07:53:15Z"},{"event":"reopen","at":"2026-10-02T23:30:31Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 101 · green card filings: 27","filings_12m":101,"filings_prev_12m":150,"green_card_filings_12m":27,"median_offered_wage_usd":146797,"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":27,"band":"fade","label":"Fading","p_open":1,"p_active":0.76,"p_room":0.36,"age_days":104,"expected_fill_days":55,"reasons":["conf:8","velocity","win:tail","crowd:brand"],"computed_at":"2026-11-05T05:54:30Z"},"pay":{"stated_usd_annual":300700,"is_top_pay":true},"html_url":"https://alion.io/job/moderna-inc-director-cmc-stability","json_url":"https://alion.io/job/moderna-inc-director-cmc-stability.json","meta":{"generated_at":"2026-11-05T13:46:23Z","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":17740,"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":5847},"rest":"https://alion.io/mcp/rest/get_company?id=5847"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmoderna-inc-director-cmc-stability"},{"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%2Fmoderna-inc-director-cmc-stability"},{"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%2Fmoderna-inc-director-cmc-stability"},{"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/moderna-inc-director-cmc-stability\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmoderna-inc-director-cmc-stability"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":390411}},{"tool":"search_jobs","arguments":{"company":"modernatx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":390411},"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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