Biomanufacturing/ Biopharmaceutical/ Process Technology

The Center of Workforce Innovation for Research and Development’s Biomanufacturing/ Biopharmaceutical/Process Technology Pathway focused on the need for education of new employees needed in the Biopharmaceutical and Biomanufacturing sector of New Jersey.  Efforts have been developed to introduce individuals to careers in these fields, ranging from a summer exploratory program for students in high school through the up-skilling of incumbent workers. 

Middlesex College developed a Summer Exploration Program (“Pathways to Biotechnology”) for high school students who are interested in biotechnology (encompassing biomanufacturing and biopharmaceuticals).  High school students who have completed one year of biology and one year of chemistry are eligible for the program.  Fliers advertising this program to Middlesex County high schools will start in early February.  Sixteen students will be chosen by lottery from the applicants. The program will run from June 26, 2023 through Aug 3, 2023 from 9 a.m.-2 p.m. as a pilot course to confirm the feasibility and functionality of the exercises designed.  The initial pilot program will be funded by the Research & Development CWI and there will be no cost to the students.  

The program objectives/learning outcomes and a lab manual containing all of the lab exercises is completed. At the end of this first running of the program, introductions to all of the lab exercises, lecture presentation materials and the lab protocols will be made available to all community colleges for their use for students in their counties.  In addition, suggestions for outside speakers and/or activities will be included (lists/contacts).   

Students currently in degree programs at Middlesex College will be made aware of career opportunities in Biopharmaceutical/Biomanufacturing that they may not have considered when they entered the Process Technology A.A.S. program at Middlesex College.  Middlesex College reviewed and revised the curriculum for the Process Technology A.A.S. degree that now will recognize the 6 credits students will earn after they complete the non-credit Biomanufacturing curriculum.  

Middlesex College already has experiential learning embedded in the Process Technology A.A.S. program. Middlesex students also engage in experiential learning in BIO 240, Research in Biology, and CHM 240, Research in Chemistry, but Middlesex students have not engaged in research directly relating to biopharmaceuticals in the recent past.   

New Jersey has an extensive number of biopharmaceutical companies, including 66 in Middlesex County alone. The companies report experiencing a serious workforce shortage, especially for entry level laboratory positions. Discussions with companies, such as Janssen, have led Middlesex College to start in the development of non-credit Biopharmaceutical process technology programs to help train potential employees to ease this shortage. Dr. Robert (Bob) Bowden (Senior Director, Advanced Therapies Supply Chain, Janssen) met with us on several occasions to discuss the need for entry-level biopharma employees and has agreed to help bring other executives from biopharma companies to the table to discuss what competencies would be useful to include in our programs. In addition, Middlesex College joined NIIMBL (National Institute for Innovation in Manufacturing Biopharmaceuticals) and has the benefit of their materials and network to help shape the curriculum.  

A faculty member in the biology department at Middlesex College was contracted to design a first program that would develop competencies in Aseptic Technique—competencies required as a foundation for all other laboratory techniques one would use in this industry. This introductory course will focus primarily on the hands-on competencies associated with aseptic technique with the theory associated with these processes. The Aseptic Technique course will serve as the first course in a sequence of courses that ultimately can stack into Middlesex College’s Process Technology A.A.S. program or Biotechnology A.S. program.  Unfortunately, shortly after starting to work on the Aseptic Technique course, the faculty member had a medical emergency that sidelined him from this project. He recently returned to work and is eager to pick up this project. The Aseptic Technique course will be completed by the early summer and will run in late summer or early fall as a Continuing Education/Workforce Development non-credit course at Middlesex College.  Following the completion of the Aseptic Technique course, the faculty member intends to develop at least two additional program units—one in Cell and Gene Therapy Techniques and one in Protein Purification Techniques associated with biopharma/biomanufacturing companies. 

The stackable curriculum is envisioned as follows: 

• Aseptic Technique Certificate 
• Essentials of Biomanufacturing Certificate  
• Cell & Gene Therapy Technician Certificate (pre-requisite: completion of Aseptic Technique Certificate) 
• Protein Expression Technician Certificate (pre-requisite: completion of Aseptic Technique Certificate) 

We are currently researching whether the four non-credit courses listed above will be the complete curriculum (so that students who complete all four will earn their Biomanufacturing Process Technician Certificate) or whether there will be learning outcomes that cannot be covered within the four courses necessitating the development of a capstone course, Advanced Biomanufacturing (in which case, all five courses will constitute the Biomanufacturing Process Technician Certificate). 

The Aseptic Technique course will be completed in the early summer and the Adult Learners Pilot will run in late summer or early fall as a Continuing Education/Workforce Development non-credit course at Middlesex College.  Due to the delay in the completion of the Aseptic Technique course, professional development materials associated with this deliverable will not be available until the course is completed and has run (ETA December 2023). 

Upon learning that Raritan Valley Community College independently has begun investigating the start of a similar aseptic technique course at their campus, Middlesex College reached out and several collaborative meetings have been held to determine how we can collaborate on this endeavor.