n 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.