• Provide timely and accurate analytical testing on various APIs following both approved methodology as well as implementing research techniques using instrumentation and wet chemistry skills (SMM, USP, EP, BP, FP and JP)• Extensive experience with controlled and potent compounds in a cGMP atmosphere• Developed and improved upon existing methods for HPLC and LC-MS and wet chemistry testing• Perform method validations and transfers including writing protocols and completed… Show more • Provide timely and accurate analytical testing on various APIs following both approved methodology as well as implementing research techniques using instrumentation and wet chemistry skills (SMM, USP, EP, BP, FP and JP)• Extensive experience with controlled and potent compounds in a cGMP atmosphere• Developed and improved upon existing methods for HPLC and LC-MS and wet chemistry testing• Perform method validations and transfers including writing protocols and completed reports• Member of the Research and Development team, a cross-site team concentrated on new FDA requirements• Provide analytical assistance and expertise to external an internal customers • Trained as a cGMP Auditor for the R&D group, as well as served as a representative on the Audit and Observation Committee• Write and review pertinent SOPs• Act as Training Facilitator for Business Support Group• Provide training to other R&D staff members on LC-MS, HPLC and wet chemistry techniques• Performed USP Microbiological testing using aseptic techniques• Excellent organizational and time management skills Show less

• Perform chemical testing following approved methodology, assuring potency, purity, safety and stability of product, supporting both Chromatography and Raw Materials (USP, EP, JP testing)• Knowledge of laboratory techniques as well as laboratory instrumentation such as HPLC, GC, FTIR, NIR, and UV/Vis, manual and auto titrations• Skills include assay by HPLC and titration, water content, viscosity, specific rotation, heavy metals, particle size, identification tests, arsenic, lead, pH… Show more • Perform chemical testing following approved methodology, assuring potency, purity, safety and stability of product, supporting both Chromatography and Raw Materials (USP, EP, JP testing)• Knowledge of laboratory techniques as well as laboratory instrumentation such as HPLC, GC, FTIR, NIR, and UV/Vis, manual and auto titrations• Skills include assay by HPLC and titration, water content, viscosity, specific rotation, heavy metals, particle size, identification tests, arsenic, lead, pH, melting point, ROI, and LOD Show less