Managing Talent Risk in Emerging Cell and Gene Therapy Biotechs

Cell and gene therapies (CGT) represent a paradigm shift in how diseases are treated, requiring precise processes and highly specialized knowledge.

For approximately 15 years, CGT has evolved and transformed drug development, bringing hope to countless patients. Unlike traditional pharmaceuticals, CGT products are often individualized, time-sensitive and biologically complex. As such, personnel expertise is not just a key asset—it is a fundamental risk factor. For early-stage CGT companies, missteps in hiring, training or quality oversight can have profound implications.

From my personal experience, talent varies in their capabilities, and a professional with limited experience but high enthusiasm can be a great candidate for learning and development opportunities. On the other hand, an experienced professional, especially in a start-up environment, can be a great asset to a company in the discovery stage. Several times, I have witnessed associates joining an organization with good experience in commercial pharmaceutical manufacturing, only to expect to operate under the same processes in a development organization. A risk could arise from the lack of experience in the start-up world, as the regulatory expectations are not similar.

The price for hiring associates with only heavy commercial experience becomes evident in obstructing development and leveraging undue pressure that may stifle innovation. For example, in the development stage, there might not be enough batches to perform all the stability timepoints necessary for submissions. Hiring talent with appropriate experience, training them and providing them with the necessary leadership and guidance is crucial for the success of CGT organizations. Furthermore, in the early stages, close collaborations between Research and development, CMC, operations and quality is crucial.

Below is a discussion of risk-mitigation strategies to successfully approach the challenge of hiring and integrating the best industry associates who fit the specific CGT environment.

Talent Acquisition as a Risk Control Measure

Common Pitfalls:

• Hiring generalists for roles requiring deep specialization
• Misalignment between individual roles and company development stage
• Underestimating the importance of cross-functional communication and adaptability

Mitigation Strategies:

• Develop role-specific hiring criteria tied to phase-appropriate milestones (e.g., Investigational New Drug submission, Phase I trials).
• Use interim or consulting professionals to fill expertise gaps during early growth
• Engage quality and regulatory leaders in the hiring and onboarding process

Building Quality Systems that Enable People

Early Quality Investment as a Safeguard:

Too often, quality systems are treated as a post-clinical priority. However, quality is the infrastructure upon which people perform reliably. Delayed implementation increases the risk of batch failures, regulatory delays and patient harm.

Best Practices:

• Introduce scalable, phase-appropriate quality systems
• Implement training programs that emphasize the why of compliance, not just the how
• Integrate quality performance indicators into organizational goals and metrics

Protecting Patient Safety through Workforce Excellence

Unique CGT Challenges:

• Chain of identity and custody for personalized products
• High variability in raw material sources
• Manual processing steps increasing room for error

Training as a Compliance Imperative:

• Prioritize operator training and real-time deviation tracking
• Use risk-based training models tailored to CGT-specific hazards
• Monitor human error trends to inform continuous improvement

Business Outcomes and Human Capital Risk

Long-Term Impact of Early Decisions:

• Delays due to failed inspections, incomplete documentation or insufficient personnel training can derail funding and partnership opportunities
• Conversely, early investment in quality talent can accelerate time-to-market, enhance regulatory trust and increase valuation

Strategic Recommendations:

• Appoint a Head of Quality or Quality Consultant before clinical trials begin
• Create a cross-functional hiring roadmap aligned with development phases
• Educate investors and board members on the return on investment of expertise and quality culture

Conclusion

For CGT startups, success hinges on managing human risk as diligently as scientific or financial risk. Building a knowledgeable, quality-minded workforce is essential to protecting patients, satisfying regulators and achieving commercial success. Those who invest in personnel and systems early will be best positioned to thrive in this high-stakes field.

Appendices

• Sample hiring roadmap by development phase
• Key regulatory expectations for training and personnel oversight
• Phase-appropriate quality system