{"id":3065979,"url":"https://alion.io/job/advancell-associate-director-cmc-analytical-development","title":"Associate Director, CMC – Analytical Development","company":{"id":2044873,"name":"AdvanCell","domain":"advancell.com.au","url":"https://alion.io/company/advancell","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","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":["Boston, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":170000,"max":220000,"currency":"USD","period":"year","gross":null,"usd_annual":220000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-04T21:58:19Z","employer_posted_date":"2026-09-04","last_verified_at":"2026-10-29T12:57:26Z","board_verified":true,"closed_at":null,"days_open":54,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":54},"description":"Partnering closely with Process Development, MSAT, Quality, Regulatory Affairs, and External Manufacturing partners, the Associate Director, CMC - Analytical Development provides strategic and technical leadership for analytical activities supporting the development and commercialization of ²¹²Pb-based APIs and radiopharmaceutical products.\nThe role is responsible for establishing phase-appropriate analytical strategies, specifications, and control approaches that support GMP manufacturing, product release, stability programs, and regulatory submissions.\nThe successful candidate leads CMC regulatory authoring and documentation related to analytical development and validation, reference standards, and stability programs, supporting global regulatory submissions, lifecycle management activities, and responses to health authority inquiries. The role also drives continuous improvement initiatives to strengthen analytical capability, product and process understanding, and the advancement of the company's radiopharmaceutical portfolio.\nWorking in close collaboration with Technical Development, MSAT, Quality, Engineering, and Operations, this position provides leadership across analytical method development, qualification, validation, transfer, and laboratory readiness activities to ensure robust and reliable analytical support for clinical and commercial manufacturing.\nIn addition, the Associate Director provides analytical expertise to the Sr. Director of Precursor Development and Director of External Manufacturing to support CDMO activities, manufacturing investigations, and the implementation of effective analytical control strategies. The role helps ensure alignment between internal development programs and external manufacturing operations to maintain a reliable, scalable, and compliant supply network.\nKey Responsibilities and Duties\nDevelop phase-appropriate analytical CMC strategies and ensure generation of the supporting analytical data, technical documentation, and regulatory submission packages\n\nLead the development of phase-appropriate analytical control strategies, including analytical methods and release and stability specifications for drug substances and drug products, to support product development and regulatory objectives.\n\nPartner with Technical Development, MSAT and CDMOs to support method development, qualification, validation, transfer, and troubleshooting activities, ensuring analytical methods are suitable for GMP manufacturing, release, and stability testing.\n\nEnsure analytical development activities comply with GMP requirements and applicable radiopharmaceutical regulatory standards.\n\nProvide technical leadership for regulatory interactions related to analytical methods, specification, control strategies, and comparability assessments.\n\nPartner with Quality Assurance on investigations, change controls, and audit readiness activities\n\nProvide targeted analytical support to Precursor Development and External Manufacturing for CDMO related activities.\n\nLead analytical investigation, troubleshoot manufacturing and development challenges, and drive continuous improvement initiatives\n\nMentor, coach, and develop Analytical Development staff.\n\nOther Responsibilities\nObserve the Company’s workplace, health and safety, and regulatory policies and procedures.\n\nEngage and communicate with other AdvanCell business unit staff to ensure that activities are undertaking seamlessly and effectively.\n\nAdhere to the Company’s quality management system processes and policies.\n\nOther tasks as requested by the VP, CMC and Supply Chain\n\nEssential Skills, Qualifications, Industry and Educational Requirements\nM.Sc. in analytical chemistry, pharmaceutical sciences or a related discipline.\n\nMinimum 3 years of experience in radiopharmaceutical industry with a focus on analytical and CMC development\n\nAdvanced understanding of (radio)pharmaceutical analytical method & validation, as well as quality control testing\n\nStrong understanding of GMP requirements, (radio)pharmaceutical regulations, and industry standards across product development and commercialization\n\nExcellent communication, technical writing and analytical problem-solving skills.\n\nDemonstrated ability to build, mentor, and lead high-performing CMC teams\n\nProven ability to manage multiple priorities, meet timelines, and perform effectively in a fast-paced environment\n\nCommitment to fostering a collaborative, inclusive, and diverse workplace culture.\n\nDesirable Skills, Qualifications, Industry and Educational Requirements\nExperience in alpha spectrometry\n\nExperience in GMP manufacture of radiopharmaceuticals.\n\nSound understanding of regulatory requirements and guidelines governing GMP manufacture of radiopharmaceuticals and quality control (e.g. cGMP, PIC/S, ICH).","description_format":"text","description_chars":4802,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Oncology 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