Abstract
The global biomanufacturing sector is expanding rapidly, fueled by next-generation technologies such as continuous processing and single-use systems and by rising demand for monoclonal antibodies and recombinant proteins. At the same time, reshoring of critical biologics and pharmaceuticals is reshaping the landscape, positioning biomanufacturing as a pillar of national security, economic resilience, and healthcare innovation. Yet despite this momentum, workforce shortages remain the sector’s most pressing constraint—threatening operational capacity by 2035 and underscoring the urgent need for coordinated education and training initiatives to build a diverse, innovation-ready talent pipeline. This paper explores workforce strategies derived from Biomanufacturing NEXT, a structured 2-day expert roundtable convened with leaders across education, research, industry, investment, and government. Key insights emphasize aligning job requirements with skill development, strengthening industry–academia collaboration, and expanding non-degree pathways, certifications, and mentorship models. Actionable recommendations highlight how higher education can drive new forms of partnership, outreach, and community engagement to ensure a robust workforce for biomanufacturing and other advanced industries.
Keywords
Introduction
Over the past decade, significant efforts have been made to address the growing demand for skilled professionals in advanced manufacturing (Rikala et al., 2024)—particularly as biomanufacturing expands in both size and capability (Neverova, 2022). The COVID-19 pandemic underscored critical gaps in global biomanufacturing capacity and revealed the consequences of an underdeveloped workforce strategy, especially in low- and middle-income countries (Edgeton, 2023). Limited infrastructure and shortages of qualified personnel further slowed progress (WHO, 2024). Despite recent investments, innovation, and expanded capacity, the biotechnology and pharmaceutical sectors continue to face persistent workforce obstacles, with talent supply consistently lagging behind industry demand (Bourgeault et al., 2020). Left unresolved, these mismatches could constrain market development and undermine broader economic resilience.
Recent market analyses highlight the scale and complexity of this challenge. As of 2025, the biomanufacturing sector is valued at $50.8 billion, with roughly equal contributions from next-generation biomanufacturing ($25.71 billion) and biopharmaceutical contract manufacturing ($25.1 billion) (Grand View Research, 2021). Beyond sheer growth, the momentum around reshoring has positioned biomanufacturing as both a driver of innovation and a safeguard of national security. This shift emphasizes the strategic importance of cultivating a capable workforce that can sustain and expand domestic production capacity, while also aligning workforce development with evolving industry needs. Without bold investments in workforce development, the United States risks a deepening shortfall of biotechnology talent, threatening its ability to maintain competitiveness in the global market (U.S. National Security, 2025). Governments have begun to recognize these risks. In the U.S., Executive Order 14081 (The White House, 2022) directed federal agencies to accelerate biotechnology and biomanufacturing training initiatives. Similarly, the European Union’s draft EU Biotechnology Act underscores the importance of strengthening biomanufacturing, though with a primary focus on industrial biotechnology and food rather than biopharmaceuticals (Nicoletti, 2025). These policy moves signal growing recognition that biomanufacturing is foundational to future economic and health security.
Yet, effective workforce development extends beyond policy declarations and investment. Biomanufacturing is a technically demanding and highly regulated environment. Workers must be prepared not only for advanced scientific processes but also for rigorous compliance requirements, precise documentation, and continuous improvement. As technologies evolve, so do the competencies required—making it increasingly difficult for students to transition directly from academic training into industry roles (Ra et al., 2019). Addressing these challenges calls for an integrated framework that links higher education, workforce training, and industry practice. Academic institutions must align curricula with evolving skill needs; industry partners must provide opportunities for applied training; and governments must support scalable models that reach diverse populations, including nontraditional learners and second-career entrants. This integration can ensure that the workforce is not only larger but also more adaptable and representative of the communities it serves.
This paper contributes to the growing literature on biomanufacturing workforce development by synthesizing cross-sector perspectives into an actionable framework—moving beyond descriptive accounts to offer a structured set of strategies organized around skills alignment, non-degree pathways, and institutional collaboration models. Drawing on insights from Biomanufacturing NEXT, a high-level invitational roundtable of approximately 50 stakeholders from academia, industry, government, investment, and workforce organizations convened in Summer 2024 at Santa Clara University, we aim to present strategies that bridge gaps, foster innovation, and prepare the workforce for the evolving needs of this critical sector. The paper proceeds as follows: the Methodology section describes the roundtable design and synthesis process. The Sector-Wide Challenges section examines the collaborative imperatives shaping workforce demand. The Innovative Strategies section presents a framework for building the biomanufacturing workforce. The Adaptive Workforce section outlines approaches for developing nimble training models. The Summary and Conclusions section offers recommendations, limitations, and conclusions.
Methodology
Biomanufacturing NEXT was a 2-day invitational roundtable summit convened in July 2024 at the Locatelli Center, Santa Clara University. The event was designed as a structured expert dialogue rather than a traditional conference, with sessions organized to maximize participant engagement through open discussion, targeted questioning, and cross-sector exchange.
Participant selection
Approximately 50 participants were recruited through a deliberate, multi-channel selection process drawing on advisory board nominations, established networks through the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and Santa Clara University, and direct outreach by the organizing team. Participants were selected to ensure broad representation across the biomanufacturing ecosystem, including senior leaders from large biopharmaceutical and biotechnology companies; founders and executives from early-stage and growth-stage companies; contract development and manufacturing organization (CDMO) professionals; equipment and technology providers; venture capital and strategic consulting firms; academic faculty and community college educators; and workforce and economic development organizations. This intentional diversity of perspective was central to the roundtable’s design, enabling cross-sector dialogue that reflected both operational realities and systemic workforce challenges.
Event format and data capture
The summit spanned one half-day and one full day, encompassing sessions on workforce development, innovation ecosystems, artificial intelligence and digital manufacturing, financing, and stakeholder synthesis. Sessions were structured to open with brief framing remarks or panel introductions before transitioning to open roundtable discussion, ensuring all participants had opportunity to contribute. Topics were guided by orienting questions around current challenges, opportunities, best practices, and the need for new initiatives or public-private partnerships, though facilitators allowed discussion to evolve organically based on participant input.
To ensure comprehensive and accurate capture of proceedings, a dual data capture approach was employed. All sessions were recorded and transcribed using Otter AI, providing a verbatim record of discussions. Concurrently, two graduate students in bioengineering served as dedicated note-takers throughout the summit, capturing key themes, points of consensus, and areas of divergence in real time. This parallel approach was designed to maximize fidelity and minimize the risk of gaps in the record.
Synthesis and manuscript development
Following the summit, a professional scientific writer reviewed the full transcripts and note-taker summaries to identify recurring themes and synthesize insights into a structured first draft. This draft organized findings around the core topical areas addressed during the roundtable and formed the foundation for subsequent manuscript development. The author team then conducted multiple rounds of revision, refining the analytical framing, integrating supporting literature, and developing the recommendations presented in this paper. To support accuracy and strengthen the validity of findings, draft manuscripts were shared with roundtable participants, who were invited to offer feedback and corrections prior to submission. This step helped ensure that the synthesized insights accurately reflected the range of perspectives expressed during the summit.
Sector-wide challenges and the case for coordinated response
Workforce development in biomanufacturing is a critical factor in sustaining innovation and competitiveness in the biopharma industry, particularly as the sector seeks to retain its existing talent pool. As the industry evolves, the need for a skilled and diverse workforce has become increasingly urgent. The industry spans a wide range of roles—from technicians and lab personnel to process development experts, managers, and executives—each requiring distinct competencies. Addressing these needs calls for a comprehensive approach that integrates economic strategy, targeted training, and non-degree pathways. In North Carolina, for instance, prioritizing workforce development led to a 13% increase in manufacturing employment (Edgeton, 2023). Biomanufacturing is economically significant, contributing directly to the U.S. bioscience sector (The U.S. Bioscience Economy, 2023). According to the Biocom California’s Life Science Economic Impact Report, 31.2% of life science payroll employment in California was in biomanufacturing in 2024, underscoring the sector’s critical role in the state’s industrial base. Nationally, manufacturing accounted for 29.7% of U.S. life sciences employment, spotlighting the manufacturing backbone driving innovation across the country (Biocom California, 2025). It can act as either a bottleneck—if constrained by workforce shortages and manufacturing capacity, as seen during the COVID-19 pandemic—or an accelerator, when well-aligned with innovation needs and scaling effectively. A recent federal report emphasized the urgency of strengthening capabilities in this sector, citing its impact on innovation, reduced reliance on foreign production, and broader economic resilience (Benjamin, 2025). The demand for a trained workforce spans from doctoral-level researchers to entry-level production staff, and a shortage of qualified personnel may stall growth, reduce product quality, and ultimately limit patient access to life-saving treatments (Hopewell et al., 2024).
Workforce challenges and talent pipeline gaps in biomanufacturing
Roundtable participants—spanning education, industry, and workforce development—converged on a central finding: existing training programs frequently prepare graduates for the wrong version of the job. Academic curricula emphasize theory and broad scientific knowledge, while industry expectations center on consistency, process adherence, and immediate operational readiness. Compounding this, job descriptions often misrepresent actual hiring criteria, creating a filtering problem that disadvantages otherwise capable candidates. As one roundtable participant (James D. DeKloe, Distinguished Professor of Biological Sciences and Biotechnology, Solano College) summed it up (paraphrased here), “United States must establish coordinated, flexible education and training pathways—linking high schools, community colleges, universities, and industry—to build the workforce needed for the bioeconomy. These pathways should offer seamless progression between credentials, multiple entry and exit points, and nationwide adoption of models that have succeeded regionally.”.
Participants also emphasized that understanding sector drivers—new technologies, regulatory shifts, and evolving business models—is essential for identifying emerging skill gaps (The White House, 2023). Without this market intelligence embedded in curriculum design, training programs risk producing graduates who are technically literate but operationally unprepared. For example, a job description for a Quality Control (QC) Associate may list technical skills like proficiency in High-Performance Liquid Chromatography (HPLC), but may overlook the equal importance of traits such as attention to detail. In practice, roles like these often rely more heavily on consistency, precision, and adherence to process—skills that may not be explicitly developed in traditional academic programs.
Strengthening industry–academia collaboration for skills alignment
Given the structural disconnect identified in the Workforce Challenges subsection, the question becomes not whether academia and industry should collaborate, but how to institutionalize that collaboration at a level that produces durable change. Traditional degree programs were not designed to train a biomanufacturing workforce (AACSB International, 2024), and incremental adjustments to existing curricula are unlikely to close the gap. What is needed are formal structural mechanisms—built jointly by academic institutions and industry partners—that make skills alignment a continuous, embedded process rather than a periodic correction.
These partnerships may take the form of advisory boards, joint curriculum committees, and feedback mechanisms—structural forms of collaboration shown to align educational programs with industry needs and regional economic goals (Ahmed et al., 2022). Involving industry professionals in curriculum development helps ensure that programs reflect emerging technologies and real-time workforce needs, keeping training relevant and enhancing student employability. Additionally, collaboration offers students critical hands-on experiences—such as internships, co-ops, and apprenticeships—co-designed with industry partners. These opportunities allow students to apply classroom knowledge in real settings and gain insight into daily operations of biomanufacturing facilities. Roundtable participants noted that the lack of practical experience is a significant barrier to employment for many graduates. Structured internship programs, developed with employer input, can provide both mentorship and targeted training. Feedback from these experiences can also inform ongoing curriculum improvements.
Integrating technology and digital learning platforms can also strengthen academic-industry collaboration. Virtual labs, simulations, and online modules co-developed with industry experts offer flexible, scalable ways for students to build practical skills. Ideally, these would include modular, stackable credentials to support ongoing upskilling and reskilling. By enabling continuous learning, academic institutions can help close the gap between current workforce capabilities and future biomanufacturing demands.
Public sector partnerships to expand training pathways
The involvement of the public sector is vital to advancing workforce development and expanding training pathways that sustain regional talent pipelines. Public investment can provide essential funding and resources to launch and sustain training programs, research efforts, and infrastructure. For example, the success of North Carolina’s workforce development programs (Fraher and Ricketts, 2016) was significantly bolstered by public sector support through tobacco settlement funds. Public policy can also play a catalytic role by incentivizing industry to co-invest in strategic workforce initiatives. These investments can accelerate the growth of biomanufacturing hubs, attract industry partners, and support regional economic development. As a North Carolina based roundtable participant (Michael Dzuricky, Director, Advanced R&D, Isolere Bio, a Donaldson Company) commented, “Forward-looking investments to train a modern workforce have effectively upskilled individuals from unrelated fields into bioprocessing and biomanufacturing. However, there is still room for improvement. By training many people in a narrow skill set, we risk creating a surplus of replaceable labor—leaving them vulnerable to macroeconomic cycles. A community that strengthens partnerships between academic programs and industry for continued education will dramatically boost the resilience of its entire ecosystem”.
Public sector support also extends to regulatory and policy alignment that fosters industry-academia collaboration. Incentives such as tax breaks for companies that support training programs or grants for institutions that align curricula with industry needs can drive sustained engagement (Zhao et al., 2024). Roundtable participants expressed strong consensus that public-private partnerships are essential to building robust, regionally tailored training programs. By pooling resources and expertise, these partnerships can expand the scope and impact of workforce initiatives, ensuring programs deliver measurable economic value. Aligning training with real workforce needs ensures graduates are job-ready and companies can access the talent required to remain competitive—contributing to both economic growth and a more resilient biopharma sector. The industry tax credit–funded evergreen investment fund in New Jersey (Dunning and Wallace, 2024) illustrates a promising model that could be adapted for workforce development, particularly when contributing companies stand to benefit directly from a more capable labor force. Public agencies also play a critical role in coordinating stakeholders and aligning efforts with broader economic and workforce development strategies.
Community engagement to broaden access and diversify the talent pipeline
A diverse workforce is a strategic imperative for sustaining the biomanufacturing talent pipeline, driving innovation, and improving industry performance. Engaging community organizations, schools, and media can broaden awareness. Studies show that integrating biotechnology topics into both formal and informal learning environments enhances student understanding (Jimenez et al., 2022). Introducing biomanufacturing concepts into K–12 curricula and community colleges—through hands-on activities, science fairs, and industry visits as well as retraining programs—can help demystify the field and position it as an exciting, viable career path (Green et al., 2021). Participants also discussed the potential of recruiting and retraining individuals from unrelated industries. This approach helps raise awareness of biomanufacturing as a career option for a wider audience. One roundtable member (Roger Lias, Global Head of Biologics, Kymanox) shared his experience (paraphrased here), “Biomanufacturing operations require disciplined, detail-oriented individuals with strong documentation and process replication skills—qualities often found in mature, second-career candidates rather than exclusively fresh graduates. While scientists and engineers remain essential, recruitment should focus on training capable, responsible workers for CGMP environments, regardless of prior scientific background.”.
Mentorship programs also play a vital role in developing a sufficiently broad and robust biomanufacturing workforce, as multiple approaches are required to meet the growing need, and multiple sources of new members of the biomanufacturing workforce. Engaging underrepresented students in structured mentorship increases the likelihood of career advancement (Romney and Grosovsky, 2021). Connecting early-career professionals with experienced mentors can offer guidance, support, and critical networking opportunities. These programs should be tailored to address challenges faced by individuals from diverse backgrounds, offering practical advice and resources. Combining community outreach with flexible, affordable education options can help attract a more inclusive talent pool to the biomanufacturing workforce. Figure 1 illustrates how these varied entry points flow through distinct training pathways — degree programs, certifications, apprenticeships, and non-degree options — into biomanufacturing roles, and how career roadmaps and lifelong learning support ongoing progression within the sector. Biomanufacturing Workforce Pipeline. Flow from entry point through training pathway into industry roles, with arrows indicating general direction of progression. Lateral transitions across roles are equally encouraged, as described in the Career Roadmaps subsection. Entry points are not mutually exclusive; individuals may access multiple pathways simultaneously or sequentially. CGMP: Current Good Manufacturing Practice; HPLC: High-Performance Liquid Chromatography.
Innovative strategies for building the biomanufacturing workforce
The challenges documented above — misaligned curricula, fragmented training pathways, and underutilized community and public sector partnerships — point toward three interconnected strategic imperatives, each requiring coordination across institutional boundaries. The framework presented here moves from skills architecture through accessible career pathways to the long-term infrastructure of lifelong learning. Together, these elements form an integrated response to the structural gaps that no single institution, program, or policy lever can address alone.
Building skills and stackable credentials
Skills taxonomy by biomanufacturing role level.
1. Defining skills and competency expectations
Thorough job analyses can help identify the specific skills and competencies required for each role, enabling academic programs to align curricula with workforce needs (Wills and Bartels, 2024). This process should involve input from current employees, supervisors, and industry experts to ensure a realistic understanding of role-specific demands. Clearly defined hiring criteria are essential for guiding curriculum design. Competency frameworks—detailing the expected skills and behaviors at each job level—should be integrated into job descriptions, performance reviews, and career development plans. Without this foundation, training programs risk optimizing for the wrong outcomes — producing graduates who meet the criteria written into job descriptions rather than the competencies actually required on the floor.
2. Developing certifications and customized training programs
Certifications can formalize the blend of technical and soft skills needed for key roles, as further expanded upon in the Building Skills and Stackable Credentials subsection. For example, a Bioprocess Technician certification might include modules on aseptic techniques, equipment maintenance, and teamwork. Such certifications can serve as entry points for new workers or retraining tools for career transitions. By offering a balanced focus on both technical proficiency and soft skill development, these programs address common gaps in workforce readiness (Grubb et al., 2024). Critically, certifications function not only as entry credentials but as a shared language between employers and training providers — one that makes competency expectations explicit and portable across institutions and regions.
3. Supporting on-the-job development and continuous learning
Where the Industry–Academia Collaboration subsection addressed the structural mechanisms that institutions build together, this section focuses on what happens after the hire: the operational practices that companies must implement to convert credential-holders into effective contributors. Structured onboarding programs—distinct from generic HR induction—should map directly to the competency frameworks established during hiring, identifying gaps early and routing new employees into targeted training rather than generalized orientation. Regular skill assessments, conducted in partnership with local training institutions and workforce agencies, enable companies to track development and recalibrate training as technologies evolve (Lavrynenko et al., 2018). Mentorship plays a distinct role at this stage: not as a retention tool, but as a mechanism for transferring tacit knowledge—the process intuitions, compliance instincts, and cross-functional judgment that cannot be credentialed but are essential in CGMP environments. Roundtable participants were consistent on this point: practical, hands-on environments are where soft skills like critical thinking, adaptability, and teamwork are actually formed, not just assessed. Building a culture of continuous learning at the organizational level—where upskilling is expected, resourced, and recognized—is what ultimately determines whether a biomanufacturing workforce can keep pace with an industry defined by rapid technological and regulatory change. In this sense, on-the-job development is not a complement to formal training — it is the mechanism by which formal training is validated, extended, and made durable in the context of real biomanufacturing operations. Figure 2 illustrates how these operational practices are embedded within a broader collaboration model — showing the structural mechanisms through which academic institutions and industry partners jointly support skills development, from curriculum design and credentialing through to on-the-job mentorship and continuous learning. Industry–Academia Collaboration Model. Structural mechanisms that connect academic institutions and industry partners in support of biomanufacturing workforce development. Bidirectional arrows indicate that collaboration flows in both directions — industry informs curriculum design and provides applied training sites, while academic institutions supply trained graduates and generate knowledge that supports industry innovation.
Non-degree pathways for career mobility
The skills architecture outlined in the Workforce Challenges subsection depends, for its reach and equity, on pathways that extend well beyond traditional 4-year degree programs. Non-degree options — certificate programs, apprenticeships, and short-term courses — deliver targeted, accessible training aligned with the specific competency needs identified through job analysis, supporting recruitment, retention, and adaptability across a broader and more diverse talent pool. Colleges can further support these efforts through dual-enrollment opportunities and early mentorship to guide students in career planning (Bettencourt et al., 2021).
Mentorship is a cornerstone of successful non-degree pathways, offering guidance, industry insight, and support to those pursuing careers in biomanufacturing (Green et al., 2021). Mentors help mentees navigate career decisions, build networks, and gain relevant skills, fostering both individual growth and a sense of belonging within the industry. Structured mentorship has been especially effective in supporting first-generation students pursuing STEM careers (McKean et al., 2024). The roundtable highlighted the importance of hands-on experience in preparing the next generation of biotech workers, and emphasized that combining non-degree pathways, meaningful mentorship, and practical training can significantly strengthen the biomanufacturing workforce.
Career roadmaps for lifelong learning and progression
Credentials and pathways create the conditions for workforce entry; career roadmaps determine what happens next — providing the navigational structure that converts initial qualification into sustained professional growth. Career roadmaps offer a strategic tool to align job descriptions with required skill sets, fostering a shared understanding between employers and employees of the expectations and competencies needed for various roles. Roadmaps should span from entry-level roles, such as technicians and lab assistants, to advanced positions like supervisors, process development specialists, and business leaders. Each stage should outline the necessary technical skills and industry knowledge, as well as essential soft skills such as communication, teamwork, and problem-solving. These tools help individuals understand what competencies they need to develop to advance and what roles are logical next steps. In addition to vertical progression, roadmaps should highlight lateral movement across functions—for example, a manufacturing associate transitioning into quality assurance or management. By clarifying these opportunities, organizations can improve job satisfaction, retention, and long-term employee engagement. Importantly, roadmaps must remain dynamic, reflecting the evolving nature of biomanufacturing. As new technologies and practices emerge, the skills required will shift—making regular updates to career paths essential for workforce competitiveness (Vogt et al., 2023).
Building an adaptive and nimble biomanufacturing workforce
The biomanufacturing industry requires a workforce that can quickly adapt to evolving technologies and processes. To meet this need, training programs should prioritize flexibility, regional relevance, and a strong foundation in both technical and transferable skills.
Customized training programs and pilot certification programs
Addressing workforce challenges effectively calls for the implementation of customized training programs that standardize essential competencies while emphasizing transferable skills and industry-critical principles. These programs should be tailored to regional needs, reflecting variations in industry focus, available resources, and workforce demographics. Leveraging public-private partnerships can further enhance program design, delivery, and impact. A pilot certification program could offer a structured mechanism to validate core competencies, particularly at the regional level. By emphasizing transferable skills, such a program would help individuals transition efficiently across roles and adapt to shifting industry demands. The certification would cover fundamental capabilities relevant across functions—from technicians and lab personnel to process development and operations roles.
Key areas of training and assessment may include aseptic techniques, quality control, and regulatory compliance, forming a robust technical foundation. In parallel, modules would reinforce transferable skills such as critical thinking, problem-solving, and communication—essential for navigating complex workflows and collaborating in multidisciplinary teams. To ensure relevance, the specific skill mix should be aligned with clearly defined workforce objectives and role requirements. A well-designed pilot program would equip participants to meet diverse challenges in biomanufacturing and support long-term workforce agility and career mobility.
Summary and conclusions
The sustained growth of the biomanufacturing industry depends not only on innovation and market expansion, but on the ability of higher education, industry, and workforce organizations to jointly develop a skilled, agile, and inclusive workforce. This white paper has outlined the sector’s most pressing workforce challenges, informed by insights from the BIOMANUFACTURING NEXT Roundtable held in Summer 2024 at Santa Clara University. Follow-up conversations at the 2025 Life Science Industry Legislative Briefing and Reception with newly elected state representatives reinforced momentum and laid the groundwork for ongoing collaboration. By elevating workforce development as a strategic priority for California’s life science economy, the roundtable participants helped position biomanufacturing at the center of the state’s innovation agenda. It is now critical that these strategies move from planning to implementation.
A unified message emerged from leaders across industry, academia, government, and workforce organizations: education and training systems must evolve to keep pace with the shifting demands of biomanufacturing and the broader bioeconomy. Central to this evolution is the adoption of agile training models that can respond to new technologies, changing job roles, and regional labor market dynamics. These models are not short-term fixes—they are strategic tools to reduce entry barriers, improve job readiness, and support lifelong learning. Their success relies on sustained collaboration among employers, educational institutions, and government to ensure alignment with real-world needs. In this ecosystem, higher education holds a unique responsibility—not only as a provider of talent, but as a convener that brings industry, government, and community together, and as an innovator that designs the educational models needed for a resilient future.
Workforce programs must be co-designed with targeted industry input, requiring commitment beyond generic feedback to ensure training relevance and outcomes. Adequate financial investment will also be critical to support rapid and scalable implementation. Future preparedness should incorporate scenario planning and workforce forecasting methods, especially for rapid response in times of public health emergencies. Models must remain adaptable to reflect shifting demand patterns, such as those experienced during the COVID-19 pandemic.
Recommendations
Roundtable participants proposed the following actions:
(1) Strengthen Industry-Academia Collaboration
Co-develop modular, stackable, and competency-based curricula to prepare students with technical and practical skills needed in today’s biomanufacturing roles. Collaborative design ensures that education stays aligned with evolving industry standards and helps close the skills gap between graduates and employer expectations. Progress might be tracked through indicators such as the proportion of curricula co-developed with industry partners, employer-reported improvements in graduate readiness at the point of hire, and reductions in average onboarding time — measures that academic institutions and their industry partners can monitor through existing advisory board structures without requiring new data infrastructure.
(2) Expand Community Engagement and Access
Outreach to K-12 schools and community colleges can raise awareness of biomanufacturing as a viable, fulfilling career path. Reaching learners early—especially those from nontraditional or underserved backgrounds—helps expand and diversify the talent pipeline. Community partnerships and outreach initiatives can demystify the field and inspire interest in biomanufacturing careers. Meaningful progress might be measured through the number of institutional partnerships established with K–12 schools and community colleges, demographic shifts in the applicant pool for biomanufacturing training programs over time, and the proportion of program participants from underrepresented or nontraditional backgrounds — indicators that reflect both reach and equity without requiring large-scale longitudinal study designs.
(3) Implement Scalable Regional Certification Programs
Regional certification programs grounded in employer-defined competencies can support both entry-level hiring and upskilling for career mobility. These programs should clearly articulate technical and soft skill requirements and include mentorship, coaching, and hands-on learning. Integrating career roadmaps will help learners visualize progression while maintaining flexibility for future innovation. Success metrics might include credential completion rates, employer satisfaction scores at six and 12 months post-hire, and 6-month job placement rates — measures that regional consortia and community colleges can track without large-scale infrastructure, and that over time would build a shared evidence base for scaling what works across geographies.
Recommended prioritization of biomanufacturing workforce strategies.
Note. Leverage assessments reflect recommended priorities based on roundtable participant insights and author judgment. Institutions are encouraged to adapt sequencing based on local workforce conditions and available resources.
Strategies in the upper-left quadrant — high-leverage and near-term — represent the most immediate opportunities for institutions and employers to act within existing resource and policy constraints. Those in the upper-right quadrant are equally high in potential impact but depend on sustained cross-sector coordination and policy alignment, making them appropriate targets for longer planning cycles. Lower-leverage near-term actions (lower-left) offer useful quick wins that build momentum and visibility, while longer-term systemic investments (lower-right), such as K–12 outreach and national policy incentives, are most effectively pursued through established public-private partnerships.
Limitations
While this paper offers actionable insights grounded in cross-sector dialogue, several limitations should be acknowledged to appropriately contextualize its findings and scope. First, the findings are derived from a single roundtable event, which, while rich in perspective, represents a snapshot of stakeholder views rather than a longitudinal or replicable data source. Broader validation across multiple convenings, regions, and industry segments would strengthen the generalizability of the strategies presented here. Second, roundtable participants were drawn from established networks spanning academia, industry, government, and investment—a composition that, while intentionally diverse, may nonetheless reflect perspectives more aligned with larger institutions and incumbent stakeholders. Voices from smaller employers, rural or underserved communities, and early-career workers are underrepresented, and future efforts should prioritize their inclusion to ensure workforce strategies are equitable and broadly responsive. Third, the regional specificity of several examples warrants caution when extrapolating findings to other geographies. Labor market conditions, regulatory environments, and institutional ecosystems vary considerably across states and countries, and the strategies outlined here should be adapted rather than adopted wholesale in differing contexts. Fourth, the insights presented are qualitative and thematic in nature. The paper does not quantitatively validate workforce outcomes, measure the efficacy of specific training models, or benchmark findings against longitudinal employment data. Future research incorporating outcome metrics—such as credential completion rates, employer satisfaction, and job placement—would meaningfully strengthen the evidence base. Finally, while this paper advocates for a suite of workforce strategies, it does not empirically prioritize or sequence them. Implementation contexts will vary, and practitioners are encouraged to assess local conditions, available resources, and near-term versus long-term needs when determining where to begin. These limitations notwithstanding, the strategies and recommendations presented here represent an important step toward building the coordinated, inclusive, and adaptive workforce ecosystem that biomanufacturing urgently requires.
The biomanufacturing industry stands at a pivotal moment. Its future depends on the creation of a coordinated, inclusive, and innovation-ready workforce development ecosystem. Career roadmaps, paired with community engagement, can strengthen long-term workforce retention and diversity. Looking ahead, public–private partnerships, regional training infrastructure, scalable certifications, and data-driven systems that embed industry expertise will not only address current gaps but also equip the workforce to anticipate and adapt to future disruptions in technology, regulation, and global supply chains. Higher education, industry, and workforce organizations must lead together—designing curricula, providing applied training, extending access, and supporting lifelong learning and career mobility—while the government enables this collaboration through sustained investment and policy alignment. Only through this shared responsibility can the biomanufacturing workforce, and other advanced industries, be prepared not just for today’s needs but for the disruptions and opportunities of tomorrow.
Ultimately, the strategies outlined in this paper will reach their potential only if the field is willing to examine not just what needs to change, but the structural conditions that have made change difficult. The biomanufacturing workforce challenge is, in significant part, a coordination challenge — one in which universities, industry, and government each hold a piece of the solution, but where the incentive structures governing each sector have not historically rewarded the kind of sustained, cross-boundary collaboration this moment demands. Academic institutions are most naturally oriented toward knowledge generation; industry toward near-term operational needs; and government funding toward program cycles that rarely align with the longer horizons of workforce transformation. None of these orientations is wrong — but together, they create a system that defaults to parallel action rather than genuine partnership. The opportunity before this field is to deliberately redesign those points of connection. Academic institutions can step forward as conveners — not just providers of talent, but architects of the partnerships and platforms that bring sectors together. Industry can move from consumers of workforce outcomes to co-investors in their production. And the government can enable both by creating policy frameworks and funding mechanisms that reward collaboration, sustain long-term initiatives, and hold all parties accountable for shared outcomes. The cost of inaction falls not on institutions, but on the patients awaiting therapies, the communities seeking economic opportunity, and the broader bioeconomy that depends on a skilled, adaptive, and inclusive workforce. That shared stake is precisely what makes this a solvable problem — and what makes the call to act together not just strategic, but necessary.
Footnotes
Acknowledgements
We acknowledge support from the National Institute for Innovation in Manufacturing Biopharmaceuticals and Equipment Junction, Inc. for serving as sponsors for Biomanufacturing NEXT. We are also grateful to the contributions of participants in the roundtable, whose insights shaped the recommendations in this paper: Taby Ahsan, VP Cell and Gene Therapy Operations at City of Hope; Carline Au, Head of Planning and Strategy at East Bay Economic Development Alliance; Sue Behrens, President at SB Executive Consulting; David Bengford, Process Development Engineer at Walking Fish Therapeutics; Trish Benton, Primary Consultant at Cell Culture Biosolutions; Nate Beyor, Managing Director & Partner at Boston Consulting Group; Angelo Cardoso, Director of Laboratory for Cellular Medicine at City of Hope; Goal Chotani, Biochemical Engineering Expert; James Dekloe, Professor of Biological Sciences and Biotechnology at Solano Community College; Salvatore DeSena, President and Chief Executive Officer at NX Development Corp; Mark Donahoe, Digital Strategy Delivery Lead at Genentech; Michael Dzuricky, Director of Advanced Research and Development at Isolere Bio (a Donaldson Company); Horacio Enriquez, Operations and Supply Chain Expert; Alex Felt, Head of Business Development at Invert; Perumal Gandhi, Co-founder at Perfect Day; Amita Goel, Founder and Chief Executive Officer at Celltheon; Anurag Goel, Chief Financial Officer at Celltheon; Sibylle Hauser, Senior Vice President of Life Sciences at Global Bridge; Nathan Ihle, Senior Vice President of Pharmaceutical Operations at Bolt Biotherapeutics; Gurdyal Kalsi, Chief Medical Officer at Asklepion Pharmaceuticals; Claire Komives, Chief Executive Officer at Equipment Junction; Matt Kremer, Business Development at Univercells Technologies (a Donaldson Company); Philip Lee, Founder and Chief Executive Officer at GeneFab;Samuel Levin, Scientific Advisor and Biotechnology Expert; Roger Lias, Global Head of Biologics at Kymanox; Chris Lorenz, Chief Technical Officer at Mahzi Therapeutics; Raghu Malapaka, Senior Director Of Business Development at BioCentriq; Sunil Maulik, Partner at AZCA.; Michael Miller, Pharmaceutical and Biotechnology Industry Expert; Lan Nguyen, Head of Corporate Development and Investment at WuXi Biologics; Martin Permin, Founder and Chief Executive Officer at Invert; Joseph Ryan, Dean of Mathematics and Sciences at Solano Community College; Geoffrey Stephens, Founder and Chief Executive Officer at AiCella; Sunil Sukumaran, Chief Technology Officer at Perfect Day; David Summa, Operating Partner at Genoa Ventures; Susan Szathmary, Executive Director at Open Biopharma Training and Research Institute; and Nimi Vashi, Senior Scientist at Deep Origin.
Funding
We acknowledge support from the National Institute for Innovation in Manufacturing Biopharmaceuticals and Equipment Junction, Inc. for serving as sponsors for Biomanufacturing NEXT.
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.