Educational background: MS degree in Bioengineering with a thesis in Tissue Engineering. Accomplished biotech operations and product line engineering manager, with 20+ years experience, and a successful record in process development, set-up, design, operation, and management of biotech production lines and transfer of product lines to contract manufacturers. Experience working on in vitro diagnostic, sequencing flow cells, MEMS and microarray devices and aseptic filling lines in a GMP controlled environment. Diversified work in managing product lines, developing and implementing process improvement projects, and operating production, raw materials, purchasing, inventory, shipping & receiving teams.* Analytical and detail-oriented problem solver with experience in operational excellence principles and lean manufacturing techniques with an emphasis on continuous improvement and problem-solving techniques.* Skilled in root-cause analysis and counter measures (RCACM), DOE, DMAIC, gauge R&R, performance qualifications, test validations, pFMEAs, and vision inspection systems on automated assembly lines.* Proficient in writing manufacturing documentation for SOPs and validations.* Over 12 years experience managing highly effective high performing teams.