Pivots: Experiential Learning to Upskill Participants for High-Wage Biotechnology Careers

This project addresses a critical workforce gap in the biotechnology sector by creating a flexible pathway into quality assurance and regulatory affairs (QA/RA) careers—key roles that ensure the safety, efficacy, and compliance of medical devices, drugs, and biologics. Although QA/RA professionals are essential to biotech product development and oversight, these roles are considered the most difficult roles to fill by 32% of biotech companies. Additionally, QA/RA is not commonly featured in traditional academic programs, leaving many job seekers unaware of this high-demand career path. This project will develop and launch an online, stackable credentialing program that provides learners with practical training, industry mentorship, and experiential learning opportunities designed in collaboration with leading bioscience employers. By equipping learners with in-demand skills and direct career connections, this project advances the national interest by promoting economic opportunity, supporting STEM workforce development, and contributing to U.S. leadership in biotechnology innovation. The program has the potential to serve as a national model for how institutions can align education with evolving industry needs to support economic growth. The proposed project will design, implement, and evaluate a three-year, asynchronous certificate program in QA/RA tailored to the needs of the biotech industry. Delivered by the University of Colorado Denver in collaboration with the Colorado Bioscience Institute and 16 industry partners, the program includes stackable micro-credentials aligned with career-relevant QA/RA functions. The curriculum will cover critical concepts such as Good Manufacturing Practices (GMP), product lifecycle regulations, documentation, and quality system controls. This Pivots-track program is designed for participants without a college degree, and incorporates flexible online coursework, industry-informed capstone experiences, and structured mentoring. The project anticipates enrolling 60 learners and will collect qualitative and quantitative data on outcomes including skill acquisition, job placement, and wage mobility. By integrating workforce development with real-world QA/RA training, the program will generate scalable models for credentialing that can be replicated by other institutions, ultimately strengthening the national biotech workforce pipeline. The ExLENT Program, supported by the NSF TIP and EDU Directorates, seeks to support experiential learning opportunities for individuals to increase their interest in and access to career pathways in emerging technology fields. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.