{"id":3065980,"url":"https://alion.io/job/advancell-director-cmc-precursor-development-manufacturing","title":"Director, CMC – Precursor Development & Manufacturing","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":230000,"currency":"USD","period":"year","gross":null,"usd_annual":230000},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"Mass Spectrometry","optional":false}],"status":"live","first_seen_at":"2026-09-04T21:50:07Z","employer_posted_date":"2026-09-04","last_verified_at":"2026-10-24T18:12:11Z","board_verified":true,"closed_at":null,"days_open":49,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":49},"description":"The Director, CMC - Precursor Development & Manufacturing is responsible for the development, optimization, manufacturing, and lifecycle management of precursor molecules and related reference standards used in the Company’s radiopharmaceutical products. This role provides technical leadership across synthetic chemistry, process development, analytical development, and GMP manufacturing of complex small molecules, including peptide-based and chelator-containing precursors.\nThe successful candidate will work closely with external contract development and manufacturing organizations (CDMOs) to build process understanding, support analytical method development and validation, and ensure alignment with global regulatory expectations (e.g., ICH, GMP). This work enables the timely delivery of high-quality drug substance and reference standards for clinical and commercial manufacturing. The Director also supports CDMO selection and shipping logistics for precursor materials.\nThe role also includes leading CMC regulatory writing and documentation to support regulatory submissions for precursors and related reference standards.\nKey Responsibilities and Duties\nLead process development, optimization, and scale-up for precursor molecules and reference standards, including small molecules and peptide-based constructs\n\nProvide subject matter expertise in synthetic organic and process chemistry, including route design, impurity control, and process robustness\n\nPartner with the Associate Director of Analytical Development to guide analytical development activities and ensure methods are GMP-ready, fit for intended use, and capable of supporting manufacturing, release, and stability programs.\n\nEnsure GMP-compliant manufacturing of precursor materials at CDMOs\n\nSupport technology transfer and scale-up activities for clinical and commercial manufacturing\n\nEnsure CMC activities align with ICH guidelines and global regulatory requirements for drug substance development\n\nPrepare and review CMC documentation for regulatory submissions (e.g., IND/CTA/MAA)\n\nPartner with Quality Assurance on deviations, investigations, change controls, and audit readiness\n\nDrive continuous improvement in process efficiency, robustness, and cost of goods\n\nSupport material specifications, control strategies, and impurity fate and purge assessments\n\nProvide technical input to supply chain planning and risk mitigation strategies\n\nMentor and develop CMC staff and foster a strong technical culture\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 coordinated 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\nPh.D. in Chemistry (preferably Organic or Process Chemistry) or related discipline\n\nSignificant industry experience (typically 6+ years) in CMC, process development, or technical operations\n\nStrong expertise in synthetic chemistry, including multi-step synthesis and impurity control\n\nWorking knowledge of analytical development and validation (e.g., HPLC, LC-MS, stability-indicating methods)\n\nAdvanced knowledge of GMP manufacturing and regulatory expectations\n\nStrong understanding of ICH guidelines and global regulatory requirements\n\nDemonstrated experience selecting and managing CDMOs and external partners\n\nExcellent problem-solving, communication, and leadership skills\n\nAbility to operate independently and effectively in a fast-paced, development-stage environment\n\nDemonstrated ability to deliver to timelines in high-pressure environments\n\nDesirable Skills, Qualifications, Industry and Educational Requirements\nExperience in radiopharmaceutical or radiochemistry environments\n\nFamiliarity with chelator chemistry and metal complexation\n\nExperience supporting regulatory submissions (e.g., IND/CTA/NDA/MAA)\n\nKnowledge of CMC strategies for early- and late-phase development","description_format":"text","description_chars":4134,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-22T07:58:01Z"}],"visa":[],"liveness":{"score":27,"band":"fade","label":"Fading","p_open":1,"p_active":0.61,"p_room":0.45,"age_days":49,"expected_fill_days":28,"reasons":["conf:4","win:tail"],"computed_at":"2026-10-24T06:02:35Z"},"pay":{"stated_usd_annual":230000,"is_top_pay":false},"html_url":"https://alion.io/job/advancell-director-cmc-precursor-development-manufacturing","json_url":"https://alion.io/job/advancell-director-cmc-precursor-development-manufacturing.json","meta":{"generated_at":"2026-10-24T18:43:21Z","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 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