TThe Analytical (Extractables and Leachables) Specialist is a key role in the pharmaceutical development group in R&D reporting directly into the R&D team manager. The candidate should have a strong organic chemistry background with analytical experience in advanced chromatographic and mass spectrometric techniques. The role has direct report responsibilities.
• The identification and control of trace-level organic compounds in packaging, medical device systems and pharmaceuticals
• Management of controlled extraction studies and development/validation of leachables methods
• Project management of internal and external contractors including budget control and approval of work orders
• Attention to detail in reviewing external protocols/reports to ensure meet quality and regulatory standards
• Perform risk assessments and integrate mitigation strategies into E&L strategy
• Participate in drug product technical team meetings delivering on project goals and milestones, on occasion take a leading role.
• Build networks in the organisation where information/learnings are shared
• Build high performing team in E&L
• Write and review high quality submission documents and reports
• Masters or BSc with between 5 & 10 years analytical experience in an R&D or an academic environment.
• Excellent communication skills
• Strong capability to organise workload based on conflicting project requirements
• Strong in problem solving skills to support investigations in R&D and commercial
• Strong leadership skills to manage internal and external teams
• Working knowledge of statistics/mathematics required
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747