{"id":3100400,"url":"https://alion.io/job/lantheus-associate-director-technical-cmc-support-pet-quality-operations","title":"Associate Director, Technical & CMC Support (PET Quality Operations)","company":{"id":2113487,"name":"Lantheus","domain":"lantheus.com","url":"https://alion.io/company/lantheus","size_band":"201-500","is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"UltiPro","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bedford, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":139000,"max":232000,"currency":"USD","period":"year","gross":null,"usd_annual":232000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-10-22T15:46:28Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-28T23:44:32Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years.\nToday, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world.\nAt Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress.\nJoin us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands.\nSummary of Role\nWe are seeking an Associate Director, Technical & CMC Support (PET Quality Operations) to provide strategic and operational Quality oversight for Chemistry, Manufacturing, and Controls (CMC) activities across the PET portfolio and external manufacturing network. This role supports regulatory submissions, technical transfers and site activation, product lifecycle management, supplier and CMO oversight, and continued compliance with applicable current Good Manufacturing Practice (cGMP) and regulatory requirements.\nThe Associate Director, Technical & CMC Support will serve as a key cross-functional partner to Technical Operations, Regulatory Affairs, Manufacturing, Supply Chain, and external manufacturing partners. The successful candidate will apply strong technical judgment and Quality leadership to resolve complex issues, maintain product and process integrity, support reliable supply, and advance continuous improvement.\nThis is a remote position open to applicants authorized to work for any employer within the United States. Travel to Lantheus and external partner sites is required, as business needs dictate.\nResponsibilities\nLead and support CMC Quality activities, including authoring, review, and approval of Module 3 content, technical reports, regulatory submissions, responses, and supporting documentation.\nProvide Quality oversight for commercial product lifecycle management, including post-approval changes, stability programs, specifications, regulatory commitments, and associated governance forums.\nProvide QA oversight for technical transfers from development through commercial readiness, including analytical and process transfer documentation, qualification activities, readiness assessments, and site activation.\nPartner with internal stakeholders and external contract manufacturing organizations (CMOs) to ensure technical documentation, manufacturing controls, and Quality systems remain aligned with regulatory expectations and Lantheus standards.\nOversee Quality performance of external manufacturing partners through risk-based monitoring, review of key performance indicators and trends, audit support, due diligence, and continuous improvement activities.\nSupport and approve deviations, investigations, change controls, corrective and preventive actions (CAPAs), qualification documentation, site procedures, and batch-related documentation, as assigned.\nEvaluate environmental monitoring data, sterility assurance programs, aseptic process simulation outcomes, and microbiological or process performance trends to identify risk and drive appropriate action.\nProvide technical Quality support for batch record review, sterility reconciliation, and product disposition activities to ensure decisions are compliant and scientifically justified.\nLead or contribute to cross-functional governance and decision-making for changes, specifications, stability, site readiness, product supply, and other technical or compliance matters.\nLead and participate in internal and external audits and regulatory inspection readiness activities, including preparation, execution, response development, and follow-up commitments.\nSupport responses to regulatory authority questions and inspections and help ensure inspection readiness across supported products, sites, and activities.\nIdentify emerging technical, regulatory, and compliance risks; communicate clear assessments and recommendations to stakeholders and senior leadership.\nMentor colleagues and promote consistent, risk-based Quality decision-making, knowledge sharing, and continuous improvement across the organization.\nBasic Qualifications\nBachelor’s degree in chemistry, pharmaceutical sciences, engineering, life sciences, or a related scientific discipline.\nMinimum of 10 years of progressive experience in pharmaceutical Quality, manufacturing, technical operations, CMC, or a related function.\nDemonstrated experience supporting sterile or aseptic manufacturing and associated Quality systems.\nStrong working knowledge of cGMP requirements and CMC regulatory expectations applicable to pharmaceutical manufacturing.\nExperience with technical transfer, product lifecycle management, deviations, change controls, CAPAs, and inspection or audit readiness.\nExcellent written, verbal, and presentation skills, with the ability to communicate complex technical and Quality matters clearly to stakeholders at all levels.\nDemonstrated ability to lead through influence, manage competing priorities, and work effectively across internal functions and external organizations.\nAbility and willingness to travel to company and external partner locations, as required.\nPreferred Qualifications\nAdvanced degree in a scientific, engineering, pharmaceutical, or related discipline.\nExperience with positron emission tomography (PET), radiopharmaceutical manufacturing, or other short-shelf-life sterile products.\nExperience with CMC regulatory submissions, including review or authoring of Module 3 content and post-approval change documentation.\nExperience overseeing CMOs, suppliers, or external manufacturing networks, including audits, due diligence, metrics, and Quality improvement plans.\nStrong technical understanding of aseptic processing, environmental monitoring, sterility assurance, analytical methods, process validation, and manufacturing facility requirements.\nKnowledge of FDA, ICH, and other relevant global regulatory requirements and guidance.\nLean or Six Sigma certification or demonstrated experience applying structured continuous improvement methods.\nProficiency with Microsoft Office applications and electronic Quality management systems.\nCore Values\nThe ideal candidate will embody Lantheus core values:\nLet people be their best\nRespect one another and act as one\nLearn, adapt, and win\nKnow someone’s health is in our hands\nOwn the solution and make it happen\nThe pay range for this position is between $139,000 and $232,000 annually.\nActual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until November 19, 2026.\nLantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any characteristic protected under applicable federal, state, or local laws and ordinances.\nAny 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 make a request to the Lantheus Talent Acquisition team at .\nLantheus is an E-Verify Employer.\nApplicants have rights under Federal Employment Law: Employee Polygraph Protection Act (EPPA); Family and Medical Leave Act (FMLA)\nFor California Applicants: Family Care & Medical Leave & Pregnancy Disability Leave; California Law Prohibits Workplace Discrimination & Harassment; Your Rights and Obligations as a Pregnancy Employee\nFor Ohio Applicants: Know Your Rights: Equal Employment Opportunity is the Law","description_format":"text","description_chars":9153,"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":["Parental leave"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-22T17:22:44Z"}],"visa":[],"liveness":{"score":52,"band":"ok","label":"Likely open","p_open":1,"p_active":0.516,"p_room":1,"age_days":5,"expected_fill_days":38,"reasons":["conf:0","agency","win:early"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":232000,"is_top_pay":false},"html_url":"https://alion.io/job/lantheus-associate-director-technical-cmc-support-pet-quality-operations","json_url":"https://alion.io/job/lantheus-associate-director-technical-cmc-support-pet-quality-operations.json","meta":{"generated_at":"2026-10-29T01:39:45Z","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":2503,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"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":2113487},"rest":"https://alion.io/mcp/rest/get_company?id=2113487"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flantheus-associate-director-technical-cmc-support-pet-quality-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%2Flantheus-associate-director-technical-cmc-support-pet-quality-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%2Flantheus-associate-director-technical-cmc-support-pet-quality-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/lantheus-associate-director-technical-cmc-support-pet-quality-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flantheus-associate-director-technical-cmc-support-pet-quality-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3100400}},{"tool":"search_jobs","arguments":{"company":"lantheus.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3100400},"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); 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