Sr. Scientist over new product development sterilization processes.

My current Responsibilities include supporting both the Quality Engineering and manufacturing departments by providing sustaining quality engineering and continuous improvement support activities. This include process optimization and continuous process improvement projects using Lean and Six Sigma methodology and Design for Manufacturing tools. This requires working with manufacturing to provide assistance in performing critical thinking, data analysis, risk based prioritization techniques as well as disciplined problem solving.

Process optimization activities include identifying opportunities with for re-design or design of equipment, tools, and fixtures to improve manufacturing processes, reduce risk and scrap. Responsibilities also required using CAPA, non-conformance investigations, root cause analysis, audit process to resolve manufacturing and compliance issues.Required exceptional problem solving skills and a solid scientific background and qualifications as well as strong data and statistical analysis skills.

Extensive experience in FDA, PDA, USP, AAMI, and ISO regulatory compliance as it pertains to the pharmaceutical drug and device manufacturing and sterilization. Responsibilities included pharmaceutical and medical device implementation of principles and practices of microbiological control, cycle design, development, qualification and ongoing control of cycle bioqualification and sterilization validation including steam, ethylene oxide and e-beam sterilization. Regulatory compliance with PDA technical Report 1; Validation of Moist Heat Sterilization Process; ANSI/AAMI/ISO 11138-1:2006, AAMI TIR No. 13-1997; ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 11134:1995.Personally instructed by Dr. Irving J. Pflug a pioneer and well published expert in the field of steam sterilization testing. The course emphasis was on increasing the level of knowledge regarding principles of sterilization science among those responsible for producing sterile pharmaceutical products. The material covered in the coarse, was focused on meeting the needs of the food, pharmaceutical and medical device industries in the implementation of principles and practices of microbiological control, cycle bioqualification and sterilization validation.

Oversaw the LAL Endotoxin testing lab for the facility. Certified Pyrogen Testing TechnicianCharles River Endosafe - 2001Personally instructed by Dr. James Cooper a world-renowned and well published expert in the field of Pyrogen testing. Dr. Cooper is one of the pioneering scientist who developed the current methodologies employed currently in the USP <85> Kenetic Turbidometric Bacterial Endotoxin Test.

Responsibilities included microbiological testing United States Pharmacopeia (USP) ,<61>, Antimicrobial Effectiveness testing USP <51>, bioburden and sterility testing United States Pharmacopeia (USP) ,<61>, <62> and <71> , environmental monitoring, process testing validation, and United States Pharmacopeia (USP) pyrogen testing.