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 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.
#J-18808-Ljbffr