t to move on to learn about process performance qualification and then production. Such a workflow reduces the time required to commercialize a product and shortens the cycle time to produce each batch, especially when process failures occur.
Bioprocesses of the future will demand more from production personnel. By necessity, autologous therapies require a greater number of production batches. On a given work shift, a great number of critical operations can affect a batch. Because single-use technologies require fewer manual operations than does traditional equipment (e.g., cleaning and sterilization), the proportion of critical operations per shift also will increase. In either case, additional process knowledge will be needed during production.
So How Do We Get There?
Education, recruitment, and training are the interconnected routes to building product and process knowledge.
Education: Students interested in entering the biomanufacturing industry need to learn and understand biology, microbiology, molecular biology, chemistry, and biochemistry. Those who want multiple job offers will supplement their studies with courses on fermentation, cell culture, downstream operations, automation, aseptic processing, and quality principles. Regulatory science, automation and professional skills also are helpful.
Universities are well suited to offer both introductory and advanced courses in scientific principles. Where such programs exist, most include hands-on laboratory activities to support the curricula. Students majoring in the life sciences can be introduced to bioprocessing careers — especially manufacturing positions — during their first year of study. Upperclassmen then can choose electives relevant to drug substance manufacturing and, if available, obtain a major, minor, or certificate in bioprocessing. Graduate courses in bioprocessing can supplement other programs or lead to a master’s degree.
Community college programs also need to deliver introductory courses, hands-on laboratory activities, and career education. Students interested in quickly assimilating into the biomanufacturing industry can take courses in applied microbiology and aseptic processing to learn the core competencies of drug product manufacturing. Unless a community college offers advanced topics and the local industry recognizes that students obtaining a two-year degree have advanced skills, students wishing to perform more complex bioprocessing operations need to transfer into a university that offers the appropriate bachelor degree(s). In this case, articulation programs with life science departments are critical.
Recruitment: The feeder pool for new production scientists is loaded with recent graduates and laboratory workers who know and understand life sciences and chemistry. Some workers even have completed additional education or training in bioprocessing fundamentals, process automation, and quality compliance.
Companies are starting to demand a higher level of education for their bioprocessing workforce. During a recent career fair held at NC State University’s Biomanufacturing Training and Education Center (BTEC), recruiters for manufacturing positions were targeting undergraduates who would graduate with bachelor degrees in biology, microbiology, biochemistry, or bioprocessing science. A quick survey of online advertisements for production positions revealed that the many biomanufacturing companies in and around Research Triangle Park, NC, require a bachelor degree. Other recruiters were looking for candidates with an associate degree and two or more years of experience, but preferred candidates with a bachelor degree. These degree requirements are justified given some of the other job duties listed in the postings:
- Understand process principles
- Understand scientific theory behind operational steps
- Write standard operating procedures (SOPs)
- Troubleshoot processes
- Conduct investigations
- Generate technical reports
- Assist in execution of validation protocols.
Training: Training programs are needed to help employees close gaps i