Master’s Degree Program in Pharmaceutical Manufacturing

Spring 2010

The Master’s Degree in Pharmaceutical Manufacturing program at the Stevens Institute of Technology - Schaefer School of Engineering is intended to integrate the study of pharmaceutical manufacturing concepts with more advanced engineering design and scientific methodologies.

This program addresses the needs of engineers, technologists, and scientists in the healthcare manufacturing industry (pharmaceutical, biotechnology, medical device, personal care product manufacturers and related GMP-driven industries). The program provides essential skills related to manufacturing technology and facilities, as subject to the industry’s regulatory requirements.

This interdisciplinary program can be customized to address many different job responsibilities within the industry. The primary path is to take virtually all Pharmaceutical Manufacturing (PME) courses, which is appropriate for those who wish to gain broad knowledge of the many facets of the industry together with some in-depth studies of certain technical areas.

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One of two degrees can be earned in this program, either a Master of Engineering Degree or a Master of Science Degree. The choice of degree is generally defined by the student’s background and the electives taken in the program:

1. A Master of Engineering Degree (MEng) can be earned if the student has a Bachelor’s Degree in engineering, and takes engineering electives; or

2. 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 types of electives.

A Bachelor’s Degree in Engineering, Technology, or Science is needed for acceptance to this Master’s program. Acceptance with other undergraduate degrees will be considered on an individual basis.

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The Master’s Degree in Pharmaceutical Manufacturing requires 30 credits (10 courses), approved by the student’s academic advisor, including:

♦ 7 or 8 courses) comprising 5 PME foundation courses and 2 or 3 PME elective courses (MS or MEng).

♦ 3 or 2 courses) comprising additional elective courses, either:

· Additional PME technical elective courses (recommended); or

· A concentration of one of the following related programs: Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Construction Management, Engineering Management, Systems Engineering, or Technology Management.

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For those students who choose to take non-PME electives, the customization program is designed as follows:

♦ For those individuals who specialize in an Engineering Discipline, such as Mechanical, Chemical, or Biomedical Engineering, electives as a concentration in one of those disciplines would further develop technical skills in those disciplines, as complementary to the pharmaceutical studies.

♦ For those individuals who specialize in Project Engineering and/or Project Management, electives in Engineering Management, Systems Engineering, Construction Management, or Technology Management would more strongly develop project and overall management capabilities in those areas.

♦ Other elective courses are available which are recommended for individuals interested in Quality, Legal Issues, Supply Chain, Logistics, Economics, Sales & Marketing, and Risk Analysis, to name a few.

♦ A wide variety of courses are available at Stevens, which would supplement the Pharmaceutical Manufacturing studies, and give the individual a closer look at other aspects of corporate operations or support. Such a customized program would be developed with each student, according to their needs and preferences.

Courses offered include the following:

PME Foundation Courses

1. PME 530 Introduction to Pharmaceutical Manufacturing ( prerequisite for most PME courses)

2. PME 535 Good Manufacturing Practice in Pharmaceutical Facilities Design

3. PME 540 Validation and Regulatory Affairs in Pharmaceutical Manufacturing

4. PME 609 Introduction to Project Management (for the Pharmaceutical Industry)*

5a. PME 639** Modeling and Simulation for Pharmaceutical Manufacturing [for Master of Engineering]

or

5b. PME 600 Engineering Economics and Cost Analysis [for Master of Science]*

PME Elective Courses

PME 531 Process Safety Management*

PME 537 Sustainable Design for Bio-Pharma Facilities (NEW!)

PME 538 Chemical Technology Processes in Pharmaceutical Manufacturing

PME 539 Biotechnology Processes in Pharmaceutical Manufacturing

PME 541 Validation of Computerized Systems

PME 542 Regulation & Compliance in the Pharm Industry [MGT 684]*

PME 551 Process Analytical Technology (PAT) in Pharmaceutical Operations

PME 560 Quality in Pharmaceutical Manufacturing

PME 580 Medical Device Design and Technology (NEW!)

PME 621** Pharmaceutical Mixing

PME 628 Pharmaceutical Finishing and Packaging Systems – Solid Dose

PME 640 Contemporary Concepts in Validation

PME 643 Design and Management of Aseptic Pharm. Mfg. Processes

PME 646 Biopharm Facilities Design

PME 647 HVAC/Building Automation Systems

PME 649 Design of Water, Steam, and CIP Utility Systems for Pharmaceutical Manufacturing

PME 653** Process Analytical Technology and its Validation

PME 660 Medical Devices Manufacturing

* PME Management courses/electives ** For engineering students

Course descriptions can be found at http://www.stevens.edu/ses/me/Graduate/pharma/index.html

Required PME electives refer to 600-level PME technical courses, of which three are required for the MEng and two are required for the MS degree.

Students may take courses emphasizing mechanical design (PME 628, 647, 649), chemical processes (PME 531, 538), biotechnology (PME 539, 646), and validation (PME 541, 640), amongst others.

Note that a four-course Graduate Certificate in Pharmaceutical Manufacturing Practices (PMP) can be earned by taking PME 530, 535, 540, and another approved PME technical elective. There are also other four-course Graduate Certificates offered in Validation & Regulatory Affairs (VRA), Design of Pharmaceutical Facilities (DPF), Project Engineering in Pharm. Mfg. (PEPM), Bioprocess Systems in Pharm. Mfg. (BSPM), and Medical Devices Design and Manufacturing (MDDM). Any of these are able to be credited towards a Master’s Degree in Pharmaceutical Manufacturing program.

Following the foundation and 600-level technical PME courses, students may write a Master’s Thesis for 6 credits, instead of other PME electives or other discipline electives.

In order to graduate with a Master’s Degree in Pharmaceutical Manufacturing, a student must obtain a minimum of “B” average in the major field, as well as an overall average of “B” in all the courses needed to meet the 30-credit requirement for the degree. Please refer to the Stevens Office of Graduate Studies information on Student Status.

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