LSC have a great contract opportunity for a Analytical Strategy & Lifecycle Director 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 15 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY 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 including:
- 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.
- 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A 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.
- 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: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Adam Murphy on +353214718214 if you have any more questions about this role!
