Pharmaceutical Manufacturing M.S. and M.Eng.
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, boasting a 90% placement rate for graduates.This exceptional proportion of graduates in the field helps Stevens continue its rise in the PayScale College Education Return on Investment rankings. Stevens places 9th in the 2013 rankings among all colleges and universities nationally for 30-year net return on investment, with graduates grossing $1.46 million in cumulative earnings above the cost of their bachelor’s degree after 30 years in the workforce.
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 is also a certified Lean Six Sigma Black Belt and Accredited Trainer in Lean Six Sigma and developed and introduced a new course in "Lean Six Sigma in the Pharmaceutical Industry" in the Fall semester of 2011.
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.
Industry Professor Vi Van Trieu has over 28 years of experience in pharmaceutical engineering, operations, management and business development. This includes feasibility studies, procurements, designing and validating complex, stand-alone cGMP facilities to campus-wide sites and centralized engineering systems in the United States, Puerto Rico and Asia. His industry pharmaceutical experience spans over 10 years of designing solid, parenteral dosage and bioprocessing facilities and 15 years in pharmaceutical manufacturing companies that included directing overall operations, 5-year CapEx and Year-over-Year Operating budgets planning, and daily facility management of biopharmaceutical processes, material management and facilities. Professor Trieu is a contributing author and subject-matter expert reviewer of engineering directives and design standards for many pharmaceutical companies and has been a speaker at trade show conferences.
Professor Trieu is registered professional engineer and a subject matter expert in all phases and aspects of Pharmaceutical Plant Design, Bioprocess Equipment and System Design including New Technologies, Compendia Water & Environmental System (HVAC) Design, Operations and Monitoring, Sustainability and Green Design facility, and Pharmaceutical Manufacturing Operations. His current active research areas are Biopharmaceutical manufacturing, Rapid Manufacturing Techniques for Vaccines and Biopharmaceuticals, Disposables and Single-Use Technologies, and Cell Line Engineering and downstream purification processes.