Analytical Strategy

4 days ago

Dublin, Dublin City, Ireland LSC, Life Science Consultants Full time
Overview

Analytical Strategy & Lifecycle Director role at LSC, Life Science Consultants. Dublin-based contract opportunity for a Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines.

Responsibilities
  • Develop and execute analytical CMC strategy for late-stage assets transitioning to commercialization.
  • Lead the design, authorship, and critical review of regulatory and technical deliverables.
  • Provide 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.
  • Collaborate 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 during complex analytical troubleshooting, method updates, validations, and tech transfers.
About You – Qualifications
  • 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).

Note: This is a contract opportunity. If you are eligible to work in Ireland, you will need to hold a Stamp 1G/Stamp 4 visa to apply. Apply via this advert or contact Adam Murphy on +353214718214 with any questions about this role.

Additional Details
  • Seniority level: Director
  • Employment type: Contract
  • Job function: Manufacturing
  • Industries: Pharmaceutical Manufacturing

We note that the page may include related job postings and location updates. This description retains the core responsibilities and qualifications for the Analytical Strategy & Lifecycle Director role.


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