Job Description
The Analytical Chemist (Extractable and Leachable) is a key role in the pharmaceutical development group
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.
Key Responsibilities include:
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
Qualifications/experience:
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
For further information on this Analytical Chemist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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