Keith J. Kociba, Ph.D. Email & Phone Number

Hands-on executive-level through individual contributor level problem-solver, leader and entrepreneur with wide range of technical and business experiences spanning 35+ years: manufacturing, laboratory, engineering, automation, validation, quality, regulatory/GMP compliance, teaching, sales, marketing, entrepreneurial. Outstanding investigation, critical review and planning skills. 8 years industrial chemistry, 3 years teaching and 25+ years of life sciences experience (pharmaceutical / medical device / cell & gene therapy) tech transfer / CQV / commercial manufacturing ranging from start-up of aseptic manufacturing facilities to performance / supervision / management of manufacturing / quality / laboratory operations to remediation of 483 / Warning Letter / Consent Decree situations in all functional areas. Work experiences range from start-up facilities to decades-old manufacturing facilities, from solid dosage forms to sterile injectables (parenterals) to medical devices to combination pharmaceutical / medical device products to research laboratories. Exemplary ability to design and execute practical strategic and tactical plans. Outstanding organization and critical review skills. Well-experienced in workflow / systems optimization. Received corporate and academic awards for quality, innovation and utility of work. Boy Scout leader, Cub Scout leader and girls’ softball coach and scorekeeper (performance metrics).

Listed skills include Validation, Gmp, Fda, Pharmaceutical Industry, and 17 others.