Job Title:ASL Scientific Director – Contractor, Analytical Strategy & Lifecycle (Analytical CMC)Duration: 12 monthsLocation:Cruiserath, DublinWorking hours:39 hours per weekOnsite requirements:Hybrid (50/50 hybrid policyEngagement Type:Contract via Ltd companyDay Rate / Hourly rate:Competitive day rateLegal Right to Work:Applicants must have the legal right to work in Ireland. Visa sponsorship is not available for this role.Job OverviewAtrium Global is delighted to be supporting our client, a leading global biopharmaceutical company, in the appointment of a Scientific Director of Analytical Strategy & Lifecycle. This pivotal role focuses on developing, managing, and executing analytical CMC strategies to transition late-stage assets through commercialisation and to support lifecycle management of commercial products.This senior individual contributor position requires deep expertise in biologics analytical sciences and strong technical writing skills to support regulatory submissions and global filings. You will operate as a subject matter expert, contributing scientific and regulatory leadership across assets while delivering high-quality outcomes independently at the highest technical standards.RESPONSIBILITIESDevelop and execute analytical CMC strategies for late-stage assets transitioning to commercialisation.Lead design, authorship, and critical review of regulatory and technical deliverables including:Justification of Specifications (JOS)Analytical Comparability Protocols and ReportsScientific Briefing DocumentsResponses to Analytical Health Authority QuestionsProvide scientific expertise for lifecycle management of analytical strategies across commercial products, including specification setting, method lifecycle management, reference standards, and comparability studies.Serve as subject matter expert in analytical sciences, advising cross-functional teams and aligning with regulatory expectations.Partner with Analytical Development, Quality, Regulatory, Process Sciences, Manufacturing, and Project Management to ensure robust execution of strategies.Provide leadership during analytical troubleshooting, method updates, validations, and tech transfers.Ensure compliance, clarity, and accuracy in all technical deliverables.Operate as a senior independent contributor, proactively driving execution of analytical control strategy.REQUIREMENTSExtensive knowledge and hands-on experience in analytical CMC for biologics, including:Specification settingAnalytical comparability strategy and risk assessmentsMethod lifecycle and change controlReference standard strategyProven track record in authoring complex regulatory and scientific documents (e.g., JOS, comparability reports, method validation summaries, regulatory responses).Experience in providing strategic input into regulatory submissions (IND, BLA, NDA, ROW, PAS) and managing health authority communications (IRs, FUMs, PMCs).Strong technical writing and communication skills with the ability to translate complex science into clear regulatory language.Ability to influence and drive alignment across matrix teams without direct authority.Solid understanding of analytical methods commonly applied to biologics (iCIEF, UPLC, CE, Bioassay, ELISA, LC-MS, etc.).In-depth knowledge of FDA and international regulatory guidelines, with significant experience supporting Health Authority inspections.Education: PhD, MS, or BS in Biological Sciences, Chemistry, or related discipline with 15+ years' biologics experience in analytical CMC or related field.