Description
SUMMARY * B.S. Biochemistry + M.B.A. Pharmaceutical Management with over 17 years of pharmaceutical industry experience * 12 Years of Parenteral Manufacturing experience. Member of PDA. Attended Courses at University Tennessee * 13 years of production experience in an FDA regulated environment such as Biopharma, OTC, medical devices in clinical, commercial drugs, consumer products, and nutraceuticals. * 11 years of production supervision/manager experience. Managed over 100 operators (75 Perm + 60 Temp) for 20 packaging lines, with equipment such as labeling, filling, bottling, case packaging, palletizing, mixing tanks, autoclaves, CIP, SIP, compounding, etc. * 7 plus years of Project Management experience planning and managing projects, defining problems, collecting data, establishing facts, drawing valid conclusions, and recommending methods, procedures and/or techniques for resolution * Extensive experience with FDA, OSHA, cGMP, safety, EPA regulations, IND/NDA submissions. * Handled all aspects of production supervision and project management like resource planning, cross-functional training, performance reviews, safety, production goal settings, KPIs, scale up, product launches and validations etc. * Managed union, non-union, and hired and fired staff per fluctuating demands Experienced with OEE, Six Sigma/5s/Kaizen, Continuous improvement, Lean Manufacturing, 5S, etc * Works well in a fast paced, Pharmaceutical and/or consumer product manufacturing environment. * Enjoy multitasking, creative thinking and planning to set priorities. Naturally boost morale and create team work which in turn increases production efficiency * Excellent team player. Communicates clearly and effectively with QA, engineering, maintenance, management validation, etc
Accomplishments
Highlights:
Keywords
