Master of Pharmaceutical Manufacturing
Master of Pharmaceutical Manufacturing
The Stevens Pharmaceutical Manufacturing program provides an essential foundation of leading manufacturing practices in processes, facilities, validation and project management. Gain a thorough science-based understanding of pharmaceutical materials and cutting-edge manufacturing facilities in the context of global regulatory requirements. Graduates of the Stevens Pharmaceutical Manufacturing program become valuable contributors to the pharmaceutical, biotech and medical device industries.
This Master of Engineering or Master of Science program is a 30-credit degree designed for recent engineering, science or pharmacy graduates seeking credentials for competitive entry into the pharmaceutical industry. The program also caters to working engineers, scientists and technologists in the healthcare manufacturing industries including, pharmaceutical, biotechnology, medical device, personal care product manufacturers and related GMP-driven industries.
GRE Required for International Applicants
Core Course Requirements for Full Degree
A Master of Engineering Degree (MEng) can be earned if the student has a Bachelor's Degree in engineering, and takes engineering electives. A Master of Science Degree (MS) can be earned if the student has a Bachelor's Degree in science, engineering, technology, or other non-technical discipline, and takes technical or management electives.
PME 530 Introduction to Pharmaceutical Manufacturing
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
PME 535 Good Manufacturing Practice in Pharmaceutical Facilities Design
Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities; issues related to process flow, material flow and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer; bio-safety levels; developing effective written procedures so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do; levels I, II, and III policies; clinical phases I, II, and III, and their effect on plant design; defending products against contamination; and building quality into products.
PME 540 Validation and Regulatory Affairs in Pharmaceutical Manufacturing
An introduction to validation concepts in plant, process, clean-up, sterilization, filtration, analytical methods, and computer systems. Learn about Good Automated Manufacturing Practice (GAMP), IEEESQAP, and new electronic requirements, such as 21 CFR Part 11. Explore master validation plans, IQ, OQ, and PQ protocols, and their relationships to GMP. Become familiar with FDA and international (EU) regulations governing current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).
PME 609 Introduction to Project Management (for the Pharmaceutical Industry)
This course deals with the problems of managing a project, which is defined as a temporary organization of human and non-human resources, within a permanent organization, for the purpose of achieving a specific objective; both operational and conceptual issues will be considered. Operational issues include definition, planning, implementation, control and evaluation of the project. Conceptual issues include project management vs. hierarchical management, matrix organization, project authority, motivation and morale. Cases will be used to illustrate problems in project management and how to resolve them.
PME 639 Modeling and Simulation for Pharmaceutical Manufacturing [for Master of Engineering]
This course will introduce students to modeling and simulation applications in pharmaceutical manufacturing. The fundamentals of discrete event simulation and the use of commercially available software to develop models of various manufacturing and service systems will be introduced. Approaches to the development of conceptual and computer models, data collection and analysis, model verification and validation, and simulation output analysis will be discussed. The modeling of chemical, biochemical and separation processes in pharmaceutical manufacturing using process simulation software will be presented. Material balances, stream reports, operations and equipment Gantt charts will be developed and process debottlenecking and cost analysis will be conducted.
PME 600 Engineering Economics and Cost Analysis [for Master of Science]
This course presents advanced techniques and analysis designed to permit managers to estimate and use cost information in decision making. Topics include: historical overview of the management accounting process, statistical cost estimation, cost allocation, and uses of cost information in evaluating decisions about pricing, quality, manufacturing processes (e.g., JIT, CIM), investments in new technologies, investment centers, the selection process for capital investments, both tangible and intangible, and how this process is structured and constrained by the time value of money, the source of funds, market demand, and competitive position.
Four-Course Certificate Program
Students are encouraged to take an integrated four-course sequence leading to a graduate certificate for the remaining four electives or four additional courses related to Pharmaceutical Manufacturing Practices. Approved four-course sequences include:
Pharmaceutical Manufacturing Practices (PMP)
An introductory overview of the industry, touching on all basic manufacturing processes, facilities design issues, validation and regulatory affairs concepts which drive the industry, and one technical elective. This is the best sequence for individuals relatively unfamiliar with the industry.
Validation and Regulatory Affairs (VRA)
For individuals who work or aspire to work in the validation part of the industry, to test and confirm that equipment and processes meet all specifications. More detailed studies of the general concepts, specific applications to computerized systems, compliance issues, and quality aspects of manufacturing.
Design of Pharmaceutical Facilities (DPF)
For individuals who work in engineering companies or who deal with facilities issues; covers overall facilities design issues, the more detailed design of water systems and HVAC systems, and the challenges required in biopharm facility design
Project Engineering in Pharmaceutical Manufacturing
For project engineers and project managers, and those aspiring to these positions in the pharm industry. Includes the overall discipline view of facilities design, a formal introduction to project management concepts, specific implementation concepts for sterile facilities, and the newer PAT concepts.
Medical Devices Design and Manufacturing
For individuals interested in the technical challenges of this rapidly growing area. This certificate includes the manufacturing of medical devices, specifically manufacturing processes, facilities design issues, validation and regulatory affairs concepts which drive the industry, and design of BioMEMS and electromechanical devices.
Bioprocess Systems in Pharmaceutical Manufacturing
For individuals who address biopharm manufacturing technical issues. Includes overall facilities issues, biotechnology processes, specific biopharm facilities design concepts, and sterile facilities approaches.