Scientific Director – Analytical Cmc

4 weeks 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

  • Asl Scientific Director

    4 weeks ago

    Dublin, Ireland Quanta Consultancy Services Ltd Full time

    ASL Scientific Director - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for an ASL Scientific Director for their large-scale new facility in Dublin.Is this you?An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project.This...

  • ASL Scientific Director

    2 weeks ago

    Dublin, Ireland Quanta Consultancy Services Ltd Full time

    ASL Scientific Director - Ireland, Dublin - 12 Month Contract One of the top 10 best companies to work in Ireland is looking for an ASL Scientific Director for their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project....

  • Senior Director, Regulatory Affairs

    5 days ago

    Dublin, Ireland Perrigouk Full time

    Select how often (in days) to receive an alert: Senior Director, Regulatory Affairs - CMC, Regulatory Operations & Lifecycle Management Location: London, GB, SW11 7BW Chatillon Cedex, FR, 92320 Ghent, BE, 9050 Dublin, IE, D02 TY74 At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All....

  • Global Portfolio Scientific Communications Director

    21 hours ago

    Dublin Pike, Ireland Novartis Ireland Full time

    Overview Global Portfolio Scientific Communications Director – Novartis Ireland Summary Leads development of scientific communication platform (scientific statements, lexicon, and scientific narrative) aligned with Therapeutic Areas for launch assets/disease area, including publication and medical education strategy and execution. About The Role Major...

  • Analytical Project Coordinator

    5 days ago

    Dublin, Ireland Life Science Consultants (LSC) Full time

    LSC have a great contract opportunity for an Analytical Project Coordinator to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 3 years of experience working in the pharmaceutical or...

  • Territory Account Manager

    4 weeks ago

    Dublin, Ireland Qbdvision, Inc. Full time

    About The RoleWe are looking for a Territory Account Manager motivated to drive new customer growth and build relationships with a portfolio of existing global pharma and biotech customers to help further drive expansion and revenue growth.What You'll OwnSales & Revenue Generation:Developing and implementing a territory sales plan associated with company's...

  • Director Financial Analytics

    7 days ago

    Dublin Pike, Ireland Optum Full time

    Overview Director Financial Analytics role at Optum. Oversees a team responsible for financial analytics and modelling in support of Optum Rx Finance and Accounting. This team works on initiatives impacting OptumRx’s top clients and the overall business, providing financial modelling and analysis related to top clients, identifying factors influencing...

  • Associate Director Publication Excellence

    3 weeks ago

    Dublin, Ireland Healthcare Businesswomen’S Association Full time

    Job Description SummaryThe Associate Director, Publication Excellence is accountable for driving excellence in publications across therapeutic areas for scientific communications, while identifying innovative solutions and advancing functional practices to be fit for the future and industry leading.The remit of accountabilities extends to assuring the...

  • Associate Director Publication Excellence

    2 weeks ago

    Dublin, Ireland Healthcare Businesswomen’s Association Full time

    Job Description Summary The Associate Director, Publication Excellence is accountable for driving excellence in publications across therapeutic areas for scientific communications, while identifying innovative solutions and advancing functional practices to be fit for the future and industry leading. The remit of accountabilities extends to assuring the...

  • Associate Director, Eee Governance

    4 weeks ago

    Dublin, Ireland Novartis Ireland Full time

    OverviewJoin to apply for theAssociate Director, EEE Governancerole atNovartis IrelandSummary: Step into a pivotal role where your expertise will shape the future of scientific engagement at Novartis.As Associate Director EEE Governance, you'll be at the forefront of implementing enterprise-wide standards and driving compliance across global medical...