Strategic Biopharmaceutical Director

4 days ago

Dublin, Dublin City, Ireland beBeeAnalytical Full time €133,000 - €193,000

Job Overview

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This opportunity is for an Analytical Strategy Director role, where you will be responsible for developing and executing analytical CMC strategies for late-stage assets transitioning to commercialization.

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Responsibilities

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  • Develop and execute comprehensive analytical CMC strategies to ensure successful commercialization of biopharmaceutical products.">
  • Lead the design, authorship, and critical review of regulatory and technical deliverables, including specifications, method lifecycle management, reference standards, and comparability studies.">
  • Provide scientific expertise to the lifecycle management of analytical strategies across commercial products, ensuring alignment with regulatory expectations and high scientific rigor.">
  • Serve as a subject matter expert in analytical sciences, advising cross-functional teams and ensuring strategic alignment with regulatory requirements.">
  • Collaborate with Analytical Development, Quality, Regulatory, Process Sciences, Manufacturing, and Project Management to execute strategies with regulatory success.">
  • Provide scientific leadership during complex analytical troubleshooting, method updates, validations, and tech transfers, ensuring seamless execution.">
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About You – Qualifications

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  • A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 15+ years of biologics experience within analytical CMC or related field.">
  • Proven 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).">
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Contract Details

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  • This is a contract opportunity.">
  • Eligibility to work in Ireland is required, with a Stamp 1G/Stamp 4 visa necessary for application.">

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