Stringent manufacturing processes and regulatory requirements create the conditions for a skilled workforce in biologic manufacturing and bioprocess development. Shortage of trained talent is a challenge for companies engaged in producing biologic therapies. There is a critical need for training to keep pace with the advancement of these technologies. With the increasing global demand for novel biologic therapeutics, many mid- and large-sized pharmaceutical companies need avenues to train existing and new employees to work in these fast-expanding domains.
No standards currently exist which define the specific biologics process and manufacturing roles and associated competencies needed, thus adding to the challenge of training the biologics workforce. Training programs in biologics manufacturing, to the degree they exist, are created company by company at high cost and offering workers no portability of their competencies. The need is ripe for an industry-wide training curriculum that can be used to prepare incumbent and new workers for positions associated with biopharmaceutical manufacturing.
Development of a training program to enable incumbent employees in the biopharmaceutical industry to acquire competencies in bioprocess development and manufacturing operations. The training program is designed to provide a cost-effective, scalable model for use across the industry and is structured in three sequential phases to determine training gaps, develop curriculum aimed at closing gaps, and establish training protocols and standards. The primary objective of the training program will be to accelerate workforce staffing to keep pace with the rapid growth of biopharmaceuticals, establish standards of worker proficiency, enhance employee satisfaction, and expand the qualified talent pool available to biopharma manufacturers.
Addresses Critical Workforce Gap: Developed a scalable training plan for continuous biomanufacturing—a rapidly emerging area with no existing U.S.-based training programs—helping NIIMBL members and industry prepare for future manufacturing needs.
Innovative Learning Model: Designed a blended approach combining classroom instruction, hands-on practice, and e-learning modules to accelerate skill acquisition for incumbent workers and new hires.
Industry-Wide Standardization: Created a curriculum framework that promotes portability of skills across companies, reducing duplication of training efforts and improving workforce mobility
Benefits to NIIMBL Members and Educators: Provides a foundation for future training centers and programs that NIIMBL members can leverage, ensuring cost-effective, high-quality training aligned with evolving technologies.
This project created a pioneering training framework to close critical workforce gaps in continuous biomanufacturing, an emerging area in biologics production. It delivered a three-day modular course with blended learning, an equipment plan, and a gap analysis revealing the lack of U.S. training options. Validated by leading biopharma experts, the initiative establishes a scalable, cost-effective model to strengthen workforce readiness and accelerate adoption of advanced manufacturing technologies.
A detailed three-day course outline for continuous mAb manufacturing, including modules, sub-topics, learning objectives, and modes of delivery (classroom, hands-on, e-learning).
Defined equipment needs, capital cost estimates, and next steps for launching the training program under future NIIMBL project calls.
Review and feedback from experts at Sartorius, Millipore Sigma, and Genentech confirming comprehensiveness and applicability of the training plan.
Role descriptions, proficiency levels, and pedagogical strategies tailored for plant technicians and technical support engineers.
Hartounian, H., Merck-NJII BTAP Project, NIIMBL National Meeting, Washington DC, June 28, 2019.
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New Jersey Innovation Institute
Merck Sharp & Dohme LLC
