This position will perform chemical analysis for chemical characterization of pharmaceutical packaging medical devices and delivery systems ("extractables and leachables"), method validation and testing assessments to meet the regulatory timing for Europe Medical Devices Regulation (MDR) across the Renal Care and Acute Therapies businesses to sustain products.
Responsibilities and Duties
o Contribute to state-of-the-art chemical characterization (ISO 10993:18) / extractables & leachables studies by supporting information collection via laboratory testing activities, method feasibility, and preparation of samples for analysis.
o With subject matter expert input, author and/or contribute to experimental protocols and reports.
o Perform routine chemical analysis including LC and GC with and without MS detection, ICP-MS, titrations, pH, UV, and TOC. Perform chemical characterization testing in support of ISO10993-18 evaluation of medical devices.
o Perform method qualification / time of use validation for E&L methods
o Contribute to the design and execution of method validation and transfer studies
o Evaluate analytical results, identify trends and exceptions and interpretation of results relative to product requirements, definitions and/or project goals.
o Competent in interpreting complex analytical data and presenting in a form that is suitable for a wide-ranging audience.
o Routinely share results and findings and provide assistance to team members regarding project work.