Pharmaceutical Manufacturing M.S. and M.Eng.

Diverse Pharmaceutical Research & Education

Located in the prosperous medical research and industrial manufacturing region of Greater New York City, Stevens incubates the latest education and research in healthcare and manufacturing. This highly interdisciplinary program, taught by both full-time Stevens faculty and distinguished industry professors, provides students with the perfect launching point for fantastic careers in industrial engineering within the medical space.

Cutting Edge Practice and Implementation

Students gain a comprehensive knowledge base to take back to their professional roles. Major pharmaceutical companies such as Bristol-Myers Squibb, Ethicon, Genzyme, GlaxoSmithKline, ImClone, J&J, Merck, Pfizer, Roche, and Sanofi-Aventis rely on the Stevens curriculum to empower their engineers to speed up time-to-market, raise productivity, improve process efficiency, reduce costs, and maintain compliance and quality assurance. Graduates gain a superior ability to oversee projects from the ground up, including product and facility design, process engineering, and industry best practices.

Career Development for Working Professionals

The Pharmaceutical Manufacturing program was developed to support students seeking advanced skills while maintaining their current employment. Besides full-time and part-time on-campus commitments, the Pharmaceutical Manufacturing program offers graduate school at your convenience through Stevens award-winning WebCampus. The full Master's curriculum is available via online delivery to give students worldwide a career edge. Throughout its history, Stevens has had a commitment to giving ambitious professionals multiple options for their advanced education, and continues serve a broad community of dedicated learners. In addition to varied delivery, the program draws on the wide resources of the campus and the region to provide students with access to leading university and industry professors. These experts bring a wealth of knowledge and experience to instructional time as well as provide insights into developing technologies and industry trends. As an intimate and supportive, yet well-connected network of academics and professionals, the Pharmaceutical Manufacturing instructors give students the upper hand in career advancement or job placement.

Regulatory Compliance, Training, and Quality Assurance

Industry Professor Elaine Lehecka Pratt has 10 years of pharmaceutical industry experience, having worked in tablet production line supervision and as Technical Training Manager for Schering-Plough Corporation. For over 20 years, she has maintained an active consultancy to the pharmaceutical industry, specializing in regulatory compliance, GMP and technical training, documentation, and quality assurance consulting. Recognized as an industry expert in the field of regulatory compliance training, she has spoken at national and international conferences of ASQ, ASTD, PDA, PMA, CMP TEA, APhS, SME, ISPI, Pharm Tech, and Interphex, and also serves on the faculty of the PDA Training and Research Institute.

Facility Process Design

A Registered Professional Engineer, Industry Professor Leonid Shnayder worked for fourteen years as a Process Manager and Principal Process Engineer for major engineering companies serving the pharmaceutical manufacturing market. His areas of expertise include finished pharmaceutical manufacturing, biotechnological processes, Clean-In-Place, and clean process utilities (Pure Steam, Water-for-Injection, USP Purified Water etc.). He was responsible for the process design of biotech facilities for Amgen, Wyeth, ImClone, finished pharmaceutical facilities for Merck, Boehringer Ingelheim, Wyeth-Lederle, and others. Prior to that he worked as a Research Scientist / Process Development with national pharmaceutical company in Russia, where he was involved in the development and optimization of various fermentation processes, including biosynthesis of penicillin, oxytetracycline and other antibiotics.

Pharmaceutical Validation and Lean Six Sigma

Industry Professor Andrew Walsh has over 20 years of Pharmaceutical Validation experience in pharmaceutical and biotech companies including 10 years at Johnson & Johnson (PRI, Ortho-McNeil & Ortho-Biotech), Schering-Plough and Hoffmann-La Roche. Andrew has experience in Utility and Equipment Qualification, Analytical Methods Validation, Cleaning Validation, Process Validation, Computer Systems Validation and Spreadsheet Validation. At Stevens, Andrew teaches several courses in Pharmaceutical Validation. Andrew developed and teaches a "hands-on" project-based course "Contemporary Concepts in Pharmaceutical Validation" where students learn about new industry concepts, such as Quality by Design and Risk Management, by developing, validating and launching a model solid dosage pharmaceutical "product". Andrew also developed and introduced a new course in "Lean Six Sigma in the Pharmaceutical Industry" in the Fall 2011 semester.

In 2009 Andrew founded the Stevens Pharmaceutical Research Center (SPRC) and is working on 20+ research projects involving Cleaning Validation including the use of Total Organic Carbon Analysis, Visual Inspection and Clean-In-Place technology. SPRC is currently engaged in funded research with several Pharmaceutical companies. Students in SPRC are trained to work in a "paperless" environment using an Electronic Document Management System, an Electronic Inventory System, an Electronic Calibration Management System, and an Electronic Training Tracking System.

Andrew is an author of ISPE's new "Risk-based Manufacture of Pharmaceutical Product" Baseline Guide (Risk-MaPP) and is leading a team of 20 industry experts developing a new Guide for ISPE and new Standard for ASTM on "Cleaning Process Development and Cleaning Validation".

Andrew is also the President of Clean6Sigma, LLC (www.clean6sigma.com) a consulting company specializing in cleaning process development and cleaning validation. Founded by Andrew in 2007, Clean6Sigma, LLC has been providing training on cleaning validation, using statistics and risk assessments for cleaning processes and providing consulting services for pharmaceutical companies nationally and internationally.