tion. 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 in their resumes. Professionals in traditional scientist roles need to learn more about cell culture, fermentation, downstream processes, aseptic processing, process control, advanced process analytics, quality tools (root cause analysis and risk management), and regulatory science. Bioprocessing professionals lacking a formal education in basic sciences will need training in biology, microbiology, molecular biology, chemistry, and biochemistry. The more hands-on the training, the better.
As usual, industry is leading the way by specifying more in-depth qualifications in its job postings. By raising the bar for production personnel’s educational requirements, employers are signaling a call to action by universities, community colleges, and training organizations. It’s time to focus on preparing graduates for positions that demand a unique blend of scientific knowledge, laboratory skills and problem-solving abilities.
The articles that follow in this featured report continue BPI’s focus on biopharmaceutical training trends (begun in its December 2016 special issue) by highlighting selected programs for building professional skills in the modern industry.
1 US Food and Drug Administration. Guidance for Industry, PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. September 2004; www.fda.gov/downloads/drugs/guidances/ucm070305.pdf.
2 US Food and Drug Administration. Guidance for Industry, Q8(R2) Pharmaceutical Development. Revision 2, November 2009; http://academy.gmp-compliance.org/guidemgr/files/9041FNL%5b1%5d.PDF.
Rick Lawless, CPIP, is the director, industry programs, at the Biomanufacturing Training and Education Center (BTEC), NC State University; email@example.com.