Three recent graduates of the Stevens master’s degree program in pharmaceutical manufacturing and engineering (PME) – Long Zhao, Wenqing Jin and Zhen Li – are serving as an integral part of a project management team bringing a new aseptic manufacturing facility online in the northern province of Heilongjiang in China.
OncoGenerix Ltd. is building a fully self-contained manufacturing site which, when completed and commissioned in 2014, will manufacture highly potent chemotherapeutic products for cancer treatments using isolator systems that will meet CFDA (China FDA), U.S. FDA and EMA regulatory requirements. The 10 acre complex will include five buildings housing administrative and laboratory facilities, an aseptic manufacturing facility, a warehouse, central utilities and staff accommodations, including an onsite restaurant. The manufacturing capacity of the site is expected to reach 30 million vials annually.
The Stevens graduates have been integrated into the facility project management team, and will ultimately transition to key supervisory roles when the facility becomes operational. They are currently involved in managing construction, commissioning, and ultimately qualification of GMP equipment, HVAC systems and utility systems. They are also handling technical translation between the U.S. and European site construction management team and the Chinese subcontractors.
All three Stevens graduates credit the Stevens PME program with preparing them for their current roles.
Long Zhao is the documentation specialist and key contact for regulatory visits. His work includes inspecting contractors’ work, helping to develop solutions for technical issues, and drawings management.
Wenqing Jin and Zhen Li are both project assistant engineers. During the construction phase they are helping with the electrical, water and fire systems.
“The knowledge we learned at Stevens is so extensive that it can be used from the construction phase to manufacturing phase,” Zhen said. “The most valuable thing I got from the PME program is a correct understanding of the modern pharmaceutical industry. We know how a good pharmaceutical company should be and we are working based on high standards.”
Long echoed some of these thoughts, saying, “The Quality in Pharmaceutical Manufacturing course taught teaches me that “quality” is the point you should think everything from. Quality cannot be compromised.” He also credits his Bioprocess Technology in API Manufacturing, Modeling and Simulation of Pharmaceutical Manufacturing Systems, and Contemporary Concepts in Pharmaceutical Validation course with training him in important skills he is currently using on the job.
Wenqing stated that he is drawing from the Good Manufacturing Practice in Pharmaceutical Facilities Design course for his work with utilities like plant steam, hot water, chill water, HVAC, clean steam, purified water and WFI. The Design and Management of Aseptic Manufacturing Facilities course is helping him with requirements for documentation, project management, FAT and SAT execution, equipment, and procedures for aseptic filling.
All three recommend the PME program.
“The PME program gave us detailed engineering and project management skills, which helped us prepare for jobs in the pharmaceutical industry,” Wenging said.
“The things you learn in the PME program are cutting edge knowledge,” Long said. “All the professors use their knowledge and experience from the pharmaceutical industry to teach you. The knowledge you learn today you can use tomorrow.”
“The professors in the PME program are amazing,” Zhen concluded.
Dmitry Itkin, CEO of Solux Corporation and project director for the OncoGenerix project commented, “The knowledge the graduates brought from Stevens substantially reduced their learning curve when it came to understand the project objectives, technology employed and compliance requirements, and each graduate was contributing on site within 30 days of arrival. Their understanding of GMP requirements and their ability to articulate these requirements to the Chinese subcontractors has proven invaluable and will ensure that the facility will meet the highest possible construction standards for both regulated and non-regulated markets around the world.”
Stevens PME Adjunct Professor Austin McDonald, who recruited Long, Wenqing and Zhen for these roles, said that they “are a credit to the university. The client has been so impressed with their abilities that they are seeking to hire more PME graduates.”
The PME graduate program is a 10-course master’s degree program that features coursework in pharmaceutical manufacturing technologies, GMP facility design, quality tools, international regulation and compliance, project management, validation and other related topics. For more information, please visit http://www.stevens.edu/ses/graduate/pharmaceutical-manufacturing-grad.html.