LINDSAY WILLIAMS5241 Man O’ War DriveMorrow, OH 45152

(513) 356-0125Lynlu787@aol.com

Qualification SummaryProfessional Analytical Development Project Leader with a diverse background in raw material and finished product drug substance analysis. Conducts complete analysis, data review and proper results documentation in accordance with industry standards. Conducts laboratory investigations, develops analytical methods, assures project readiness and troubleshoots analysis and instrumentation issues. Experience with good manufacturing and laboratory practices in an FDA regulated environment.

Professional ExpertisePatheon Pharmaceuticals Inc.

Analytical Development Project Leader/Senior Chemist (May 2015- Present) Primary customer interface for Analytical Development work. Manage development projects and

maintain timelines in AD. The primary source for analytical scientific and/or regulatory expertise for the project to ensure the project work is technically sound, results are of acceptable quality and delivered to the client on time. Ensure project readiness for execution in the lab.

Analytical Development Supervisor (November 2013 – May 2015)Supervise and assist analysts, appropriately schedule testing that ensures a level load, and coordinate vendor and training activities. Conduct laboratory investigations for sources of error and worked with Quality Assurance in the prevention of re-occurrence. Train analysts on proper method execution; analytical techniques and proper practices; current GMP; and understanding of instrumentation, including troubleshooting and minor repair. Assist in validation of SOPs, making appropriate corrections for compatibility.

Analytical Development (Dec 2011 – November 2013)Performed full analytical testing including assay, related substances and impurities, dissolution, and content uniformity. Coordinated laboratory DEA activities in a restricted environment including the transfer, tracking within the lab, and disposal of federally regulated drug substances. Assisted in method development and validation, proposing method changes and corrections.

Quality Control (February 2008 - Dec 2011)Used a proficient knowledge of US, European, and Japanese Pharmacopias to executed testing of raw materials, both active pharmaceutical ingredients and excipient materials. Frequently used UV-Vis, AA, IR (including salt pellet and plate sample preparation), HPLC, Dissolution apparatus, and Karl Fischer instrumentation, along with wet chemistry techniques to determine compliance of materials. Coordinated retention of raw materials in a climate controlled environment for predetermined periods of time, as well as maintained and tracked controlled substances both in the lab and their retention. Performed site wide chemical water analysis for TOC, conductivity, and the detection of nitrates, heavy metals, and chloride.

Education & Training2007 - Bachelorette Degree, Zoology from The Miami University in Oxford, Ohio

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