Up and coming CDMO located in Nashville, TN is looking to brig on a Principle Scientist of Extractables and Leachables following the expansion of a new facility. Apply now and grow with this future powerhouse!
Responsibilities:
- Identifies, evaluates, develops, and validates analytical methods for extractable and leachable components from pharmaceutical packaging or devices
- Sample preparation and operation of MS instrumentation, interpretation, analysis, documentation and reporting of results, integrating experimental data and results with project objectives
- Utilizing the latest state of the art MS capabilities/techniques, analytical software and databases to identify and quantify chemical species e.g. leachables, extractables, degradation/reaction products, additives, etc.
- Subject matter expert (SME) in common analytical chemistry techniques for E&L (HPLC/UPLC, LC-MS, GC-MS etc.)
- Leads experimental design, data evaluation, data trending, scientific writing and coordination of studies
- Collaborates with project teams and customers to meet project objectives, budgets and timelines
Requirements:
- Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Bioengineering or related field with 10+ years of relevant pharmaceutical industry experience OR MS with over 15+ years of relevant experience
- Expertise in a GMP manufacturing environment
- Theoretical and practical knowledge of method development and validation principles to ICH and other applicable guidelines
- Outstanding Good Documentation Practices (GDP)
- Strong background in HPLC/UPLC, LC-MS, GC-MS, E&L testing and structure elucidation
