Partnership for Workforce Development in the BioPharmaceutical Industry

We designed online training and capstone internships with emphasis on GMP, quality and risk analysis, analytical methods, automation, validation and advanced manufacturing
Categories
Incumbent worker training
Talent/ Pipeline development

Industry Need

The biopharmaceutical industry struggles with a lack of regional hands-on training, leading to graduates without necessary skills. Recruiting and retaining experienced staff is a top priority, and while online resources help, local hands-on training is essential.

Approach

The project team created training and internships for the biopharmaceutical industry, focusing on GMP, quality, risk analysis, and advanced manufacturing. In-person lectures were recorded for online use and supplemented with applied technology classes and internships. They also leveraged existing community college programs and industry partnerships to build a comprehensive program supported by NIST.

Impacts

Integrated a cGMP lecture and cGMP laboratory course with paid summer internships, creating a sequential pathway from classroom to cGMP/QC practice and into real lab settings—accelerating job readiness for community college and university students.

Demonstrated (via IRB‑approved evaluation) that community college and university interns performed comparably, expanding the viable talent pool for NIIMBL members and industry by dispelling perceived differences in preparedness.

Established cross‑institution collaboration among UNCW, Alcami, Brunswick CC, and Cape Fear CC, strengthening regional workforce pipelines and aligning academic offerings with industry expectations.

Produced digital learning content (9 recorded lectures) and a facilitator’s guide, enabling educators to reuse and scale high‑quality cGMP/cQGMP training across programs.

Value Statement/Outcomes

This project delivered a cGMP lecture, a cGMP lab course, digital content, and structured internships with measurable outcomes: 16 control interns (2018) and 12 experimental interns (2019) completed the program, with course pass rates documented and presentation performance assessed under IRB protocols. The analysis showed improved knowledge and internship performance after completing the coursework and no statistical difference between community college and university cohorts—evidence that the model broadens the qualified talent pipeline.

Outputs/Deliverables

Courses & content: cGMP lecture, cQGMP lab; 9 video lectures, facilitator’s guide, syllabi, and certificates/medallions for completers.

Participation metrics: 67 total participants (35 higher‑ed students; 4 educators + 16 mentors; 12 professionals); 16 internships (2018) and 12 internships (2019) placed across UNCW and Alcami labs.

Evaluation results: IRB‑approved pre‑internship knowledge and post‑presentation assessments showed improved competency post‑coursework and comparable performance across institution types.

Posters

McCall, J., Baden, D. G., Clark, J., Corpening, T., & Alvarez, A.., Biopharmaceutical Partnership for Workforce Training: Coursework with Applied Leads to Success, NIIMBL National Meeting, Washington, DC, June 28, 2019.

Presentations

Baden, D. G., Application of Translational Science to Disruptive Innovation in the Biopharmaceutical Industry, Cameron School of Business "Business Week", Wilmington, NC, March 27, 2019.

Baden, D. G., Clark, J., & McCall, J., Partnership for Workforce Development in the BioPharmaceutical Industry, NIIMBL National Meeting, Washington, DC, June 28, 2019.

Baden, D. G., McCall, J., & Clark, J., Partnership for Workforce Development in the BioPharmaceutical Industry, NIIMBL Member Forum, Wilmington, NC, February 28, 2019.

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Project Lead

University of North Carolina at Wilmington

University of North Carolina at Wilmington

Participating Organizations

Alcami Corporation

Alcami Corporation

Brunswick Community College

Brunswick Community College

Cape Fear Community College

Cape Fear Community College