Scientific Director – Analytical Cmc

7 days ago

Dublin, Ireland Pe Global (Uk) Full time

OverviewPE Global is recruiting for a Scientific Director – Contractor, Analytical Strategy & Lifecycle (Analytical CMC) on behalf of our client based in North Dublin.ASL Scientific Director – Contractor, Analytical Strategy & Lifecycle (Analytical CMC)Key ResponsibilitiesDevelop and execute analytical CMC strategy for late-stage assets transitioning to commercialization.Lead the 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 to the lifecycle management of analytical strategies across commercial products, including specification setting, method lifecycle management, reference standards, and comparability studies.Serve as a subject matter expert in analytical sciences, advising cross-functional matrix teams and ensuring alignment with regulatory expectations.Partner effectively with Analytical Development, Quality, Regulatory, Process Sciences, Manufacturing, and Project Management to ensure strategies are executed with high scientific rigor and regulatory success.Provide scientific leadership and guidance during complex analytical troubleshooting, method updates, validations, and tech transfers.Ensure clarity, accuracy, and compliance in all technical deliverables.Operate as a senior independent contributor, proactively driving execution of the analytical control strategy and ensuring delivery of high-quality outcomes with minimal oversight.Qualifications & ExperienceExtensive 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 of independently authoring complex regulatory and scientific documents (e.g., JOS, comparability reports, method validation summaries, regulatory responses).Demonstrated ability to provide strategic input into regulatory submissions (IND, BLA, NDA, ROW, PAS) and manage health authority communications (IRs, FUMs, PMCs).Strong technical writing and communication skills, with the ability to translate complex science into clear, compelling regulatory language.Highly skilled in leading, working within and influencing matrix teams; proven ability to drive alignment across functions 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 and standards as well as extensive experience with supporting Health Authority inspections.Education/Experience/ Licenses/CertificationsA PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 15+ years of biologics experience within analytical CMC / relevant field, respectively.Interested candidates should submit an updated CV.To apply, please call Audrey on ********** or alternatively send an up-to-date CV to audrey.mccarthy at peglobal dot net***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***#J-*****-Ljbffr

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