Responsible for managing QC projects for new and changing LNP & Pegylated drug products (clinical and commercial phase) and providing technical communication to clients regarding these drug products on behalf of the QC Laboratories. Manage timelines and provide technical oversight of the activities required to fully qualify new drug products for the QC labs.Manage a team of Qualified Scientists responsible for the review of QC chemistry & microbiology data, QC systems specialists, and QC Client Specialists. Develop, write & revise GMP documentation for method qualifications, specifications, analytical & microbiological methods, including management of change control for QC projects.

Haddock Tree Service is a family owned company servicing the greater Indianapolis area. Our services include: tree pruning, tree removal, 24/7 emergency service, tree health & safety inspection, cabling & bracing, and free estimates.

- Oversee day-to-day operations of quality control laboratory performing analysis of FDA regulated dietary supplements.- Supervise and mentor a staff of 20 chemists, microbiologists, and lab technicians. - Coordinate workflow including tracking and prioritizing samples for analytical and microbial analysis based on production needs. - Author, revise, and implement GMP policies, test methods, work instructions, and standard operating procedures. - Oversee investigations of out of specification results and implementing preventative and corrective actions. - Implement LEAN tools including 5S, Hoshin boards, and Gemba walks.

Development of new in-house analytical methods for the quality control testing of gummy vitamins, pre-blend active ingredient mixes, and raw materials.-Inositol Hexanicotinate by HPLC in gummy, pre-blends, and raw materials-Choline by LCMS (QQQ) in gummy products, pre-blends, and raw materials-Dietary Fiber as Polydextrose by IC (electrochemical detection) in gummy products and raw materials-myo-Inositol by IC (electrochemical detection) in pre-blends and raw materialsImprovement of current in-house analytical methods to improve extraction efficiency, precision, accuracy, robustness, and to reduce preparation and analysis time.Technical writing of validation protocols and summaries, analytical methods, policies, and work instructions.Instrument troubleshooting and maintenance: IC (electrochemical detection), LCMS (QQQ), HPLC, ICPMS, GC-FID, FTIR

-Secondary review of data and verification of results in LIMS.-Analytical instrument and software troubleshooting as issues arise.-Perform Out of Specification (OOS) investigations to determine root cause of OOS results, including implementing corrective actions from the investigations.-Track lab equipment calibration and instrument qualifications, including scheduling with outside vendors.-Perform daily, weekly, and monthly safety tasks: waste designation and pickup, monthly safety check, fume hood verifications, MSDS review, and safety walkthrough trainings.-Oversees the day to day activities of the lab including scheduling and ordering in the absence of the Shift Supervisor.

-Development project (Jan. 2014-April 2014)Development of a new in-house method to test Choline by LC-MS in gummy bulk products and raw materials. This included data collection/record keeping, writing of validation protocols, methods, and corresponding documents.-Operation and preventative maintenance of an Agilent 7700x ICP-MS.-Sample preparation by microwave and hotblock digestion for trace and active metal analysis by ICP-MS.-Operation of Agilent and Shimadzu HPLCs-Operation of Agilent 6410 LC-MS-Organic sample preparation for analysis by HPLC, LC-MS, and GC-Data reporting and reviewing-Updating laboratory methods and policies to improve laboratory efficiency and sample reporting turn around time

Summer internship in the analytical chemistry laboratories for a solid rocket propulsion company. Gained experience with the following instruments/techniques: ICP-OES, GC, HPLC, wet-lab, FTIR, microscopy, NMR, EPA methods. Main summer research project utilized FTIR spectroscopy.