Nick Simons Email & Phone Number

Wilmington, De, Us

Provide customer technical support for all aspects of API production, validation, quality, and regulatory.

Athens, Georgia, Us

Athens, Georgia, Us

Raritan, New Jersey, Us

• Primary responsibility is to coordinate in-process testing/ data review to insure Just In Time flow.• Perform lab event investigations to determine root cause and implement corrective/preventive actions through PR and CAPA system. • Function as a lab lead and a SME in analytical instrumentation.• Work with Technical Specialist and vendor Service Engineers to perform instrument validation, IQ/OQ/PQ, and troubleshooting. • Research/ apply new technologies (i.e. NIR, Raman) to reduce turn around times and increase lab efficiency.

New Brunswick, Nj, Us

• Manage analytical testing lab for raw materials and production polymer. Worked with process engineers to troubleshoot process problems and drive Continuous Improvement through Six Sigma/Kiazen principles. • Manage Non-Conformance Records (NCR) for product testing failures. Work jointly with PE and QE departments to indentify failure root cause, set statistical bounding, and implement corrective actions.• Worked directly with SQM to monitor and maintain outside raw material vendor quality.• Responsible for everyday operation and troubleshooting of multiple analytical instruments including Perkin Elmer AAnalyst 300 AA, Agilent 6890 GC, and Agilent 1100 LC. • Subject Matter Expert and Certified On-the-Job Trainer for analytical testing including GC, LC, Atomic Absorption (AA), FTIR, UV-VIS, and automated viscometer instrumentation. • Successfully trained 7 chemical analysts in testing and instrument analysis for Cornelia location and secondary plant build project in Athens, GA.• In-Depth work with FDA mandated systems including SOP Document Change Control, GMP, and Quality Systems/Non-Conformance management..• Work jointly with QE to perform internal audits and prep for FDA and other external regulatory audits. • Experience with instrument IQ/OQ/PQ and Test Method Validation.

Joined new venture company as scientific subject matter expert for the production of biodiesel from oils and animal tallow.Designed 1,500 gal/batch manufacturing process for multi-feedstock conversion to automotive grade biodiesel.Set up and managed quality testing lab for pre-shipment certification of biodiesel batches.

Taught Chemistry and Physical ScienceFaculty advisor for Science Olympiad

Atlanta, Ga, Us

Researched under 3 year fellowship from Oak Ridge Institute for Science and Education in the Clinical Chemistry Branch of the National Center for Environmental HealthPart of 2 person team that developed an analytical method to simultaneously detect background levels of multi-class antibiotics in human blood samples.Analytical method consisted of automated Solid Phase Extraction (SPE) cleanup followed by LC-MS/MS analysis.