Cell and Gene Therapy Recruitment: Hiring Ahead of the Milestone

From IND and pivotal trials to regulatory approval and commercial launch, successful cell and gene therapy programmes depend on having the right people in place at the right time. But for many CGT companies, recruitment starts too late.

Cell and gene therapy (CGT) development is driven by critical milestones. Investigational New Drug (IND) applications, pivotal clinical trials, Biologics License Applications (BLAs) and commercial launches all require different technical expertise, regulatory capabilities and operational leadership.

Yet workforce planning often follows funding rather than the development programme itself. Headcount is approved when investment arrives or a milestone is achieved, even though the specialists needed for the next phase should already be in place.

For CGT businesses, this disconnect can create challenges across Manufacturing and Technical Operations, Chemistry, Manufacturing and Controls (CMC), regulatory affairs, quality assurance and manufacturing operations.

So, when should CGT companies begin recruiting for their next milestone, and which roles should they prioritise?

Why Cell and Gene Therapy Recruitment Often Starts Too Late

Recruiting experienced professionals within the cell and gene therapy industry presents several challenges.

1. Hiring decisions follow funding cycles

Biotechnology companies frequently align headcount approvals with funding rounds. However, critical activities such as process characterisation, process performance qualification (PPQ), analytical development and stability studies often begin months before the next milestone is reached.

Waiting until funding is secured to start recruitment can leave significant gaps in technical expertise.

2. Specialist CGT talent is difficult to find

The talent pool for cell and gene therapy is highly specialised, particularly for companies progressing towards regulatory approval and commercial manufacturing.

Professionals with direct experience in areas such as potency assay development, viral vector manufacturing, process validation and CGT regulatory submissions are concentrated within a relatively small number of organisations.

Many of these individuals are not actively seeking new opportunities, making proactive recruitment essential.

3. Recruitment lead times are frequently underestimated

Hiring a senior CMC or regulatory affairs leader involves more than identifying the right candidate.

Search, interview processes, notice periods and onboarding all contribute to the time required before someone can become fully productive.

Senior professionals in the UK and Europe may have three-month notice periods, while US-based candidates can sometimes join more quickly.

4. Each development stage requires different expertise

The team responsible for reaching IND submission may not have the experience required to manage a commercial-scale technology transfer, lead a BLA submission or oversee post-approval manufacturing.

As programmes advance, workforce requirements must evolve alongside them.

How Far Ahead Should CGT Companies Start Recruiting?

Effective CGT workforce planning starts by working backwards from the date a specialist's contribution is required.

Rather than asking when a role needs to be filled, businesses should consider when that individual's work must begin.

Recruitment start date = Date work begins − (Search time + Notice period + Onboarding)

For example, an organisation preparing for a BLA submission may need regulatory CMC specialists and technical writers working on submission documentation long before the actual filing date.

Depending on seniority and geography, the process of securing and onboarding the right professionals can take several months.

This makes early workforce planning particularly important for leadership positions and specialist roles where the available talent pool is limited.

For organisations requiring senior leadership expertise, a specialist Life Sciences Executive Search approach can help identify experienced professionals before an appointment becomes urgent.

CGT Recruitment Timeline: Four Critical Development Milestones

The workforce requirements of a cell and gene therapy company change considerably between early clinical development and commercial supply.

Understanding these requirements can help organisations identify which roles should be recruited permanently and where contract or interim specialists can provide additional support.

1. IND and CTA: Building the Foundation for Clinical Development

Recommended hiring window: 9–12 months before filing

Key trigger: Candidate selection is complete and GMP manufacturing is approaching.

During early clinical development, cell and gene therapy companies must establish the manufacturing, quality and regulatory foundations required to progress into human trials.

Two critical permanent appointments are:

• Head of CMC: Responsible for developing the CMC strategy, selecting CDMO partners and overseeing the CMC components of the IND submission.
• Director of Regulatory Affairs: Manages the IND or Clinical Trial Application (CTA) process and coordinates early interactions with regulatory authorities, including the FDA and EMA.

Contract specialists can provide additional expertise during this period, particularly for regulatory CMC writing, GMP audits and quality agreement preparation.

Establishing these capabilities early helps companies prepare for regulatory submission while maintaining momentum across manufacturing and development activities.

2. Pivotal Trials: Preparing for Commercial-Scale Manufacturing

Recommended hiring window: Around End-of-Phase 2

Key trigger: The commercial manufacturing process is being finalised and a commercial CDMO has been selected.

Progression towards pivotal trials introduces additional complexity across technical operations, quality systems and manufacturing scale-up.

At this stage, CGT businesses should consider strengthening their permanent workforce with:

• VP CMC or Head of Technical Operations: Leads commercial manufacturing strategy and oversees the transition towards larger-scale production.
• Head of Quality (GMP): Develops and maintains the quality systems required to support regulatory inspections and future commercial activities.
• Process or Analytical Development Lead: Oversees critical process development or analytical activities, depending on the programme's greatest technical risks.

Additional contract support may be required for technology transfer, process characterisation, validation planning and regulatory CMC strategy.

One important consideration is the timing of these appointments.

Companies that secure manufacturing capacity before recruiting the specialists responsible for validation risk placing unnecessary pressure on already demanding development timelines.

For businesses working with outsourced manufacturing partners, securing specialist talent through CDMO recruitment can help support critical technology transfer, scale-up and manufacturing activities.

3. BLA, NDA and MAA: Building Regulatory Submission Capabilities

Recommended hiring window: 12–18 months before submission

Key trigger: Pivotal data is approaching, while process validation and Module 3 preparation are beginning.

As cell and gene therapy programmes move towards marketing authorisation, regulatory expertise becomes increasingly important.

A successful submission requires coordination across regulatory affairs, CMC, validation and quality functions.

Critical permanent hires include:

• VP Regulatory Affairs: Leads the global regulatory submission strategy and manages relationships with regulatory authorities.
• Regulatory CMC Lead: Oversees the Module 3 strategy, CMC documentation and responses to regulatory questions.
• Regulatory Project Manager: Coordinates submission timelines, activities and cross-functional teams.

Contract specialists can support technical writing, inspection readiness, process validation and analytical method validation.

One of the most significant recruitment gaps at this stage is the late appointment of regulatory CMC specialists and Module 3 authors.

These individuals are essential to preparing the technical documentation required for submission. Delays in securing this expertise can put pressure on filing timelines, even when clinical development is progressing as planned.

This is why BLA workforce planning should begin well before pivotal data becomes available.

Specialist Regulatory Affairs Recruitment can support companies in securing professionals with the relevant submission experience, from IND and CTA preparation through to BLA and MAA approval pathways.

4. Regulatory Approval and Commercial Launch: Preparing for Long-Term Supply

Recommended hiring window: Approximately six months before anticipated approval

Key trigger: The regulatory filing has been accepted and launch supply preparation is underway.

Regulatory approval represents a major milestone, but it is not the end of the recruitment journey.

Commercial launch requires operational capabilities that may not have been necessary during earlier development stages.

Key permanent roles include:

• Manufacturing Science and Technology (MSAT) or Person-in-Plant specialists: Provide day-to-day technical oversight of commercial manufacturing partners.
• Supply Chain and Sales & Operations Planning (S&OP) Lead: Coordinates launch inventory, supply planning and ongoing product availability.
• Commercial Quality Assurance and Qualified Person (QP) professionals: Oversee commercial batch release and relevant quality requirements, including QP certification where applicable in the EU.

Contract specialists can support regulatory authority questions, post-approval changes, secondary manufacturing sites and supplier technology transfers.

Waiting until approval to recruit these individuals can create avoidable operational challenges.

Manufacturing partners, supply chains and treatment centres must be prepared to support the transition into commercial availability.

For CGT companies, launch readiness should therefore be treated as a workforce planning priority well before the final regulatory decision.

Permanent vs Contract Recruitment in Cell and Gene Therapy

Not every critical role requires a permanent appointment.

For small and mid-sized biotechnology companies, particularly those operating through CDMO partnerships, a combination of permanent and contract recruitment can provide greater flexibility.

Permanent recruitment is generally best suited to leadership positions and roles requiring long-term ownership of manufacturing, quality and regulatory strategies.

These individuals provide continuity as programmes progress through multiple development milestones.

Contract and interim recruitment can be particularly effective for specialist activities with defined project timelines or temporary peaks in workload.

Examples include:

• Process performance qualification (PPQ) campaign
• Technology transfer projects
• Comparability studies
• Regulatory CMC writing and Module 3 preparation
• Inspection readiness activities
• Specialist FDA or EMA regulatory responses

Where an urgent recruitment gap exists, an experienced contract or interim specialist may be available within approximately 2–6 weeks, depending on the role and market.

This can provide valuable support while a permanent search is underway or while businesses await longer-term headcount approval.

Businesses requiring immediate expertise can also explore the Barrington James Contractor Hub, which provides access to a selection of pre-vetted specialists available for project-based assignments.

Three Common Workforce Planning Mistakes in CGT

Through our work supporting cell and gene therapy organisations, several recruitment challenges emerge across different stages of development.

Hiring Only After a Funding Round Closes

Funding may unlock recruitment budgets, but the technical work required for the next milestone often begins much earlier.

Companies can reduce this disconnect by identifying critical future roles during investment planning, rather than waiting until funding is secured to begin considering headcount.

Recruiting Validation Specialists After Manufacturing Timelines Are Set

Securing a CDMO manufacturing slot is an important step towards commercial readiness.

However, validation specialists should ideally be involved early enough to shape the relevant processes and protocols.

Recruiting a PPQ lead shortly before a scheduled validation campaign can leave them responsible for delivering and defending work they had limited opportunity to influence.

Waiting Until Approval to Build Commercial Teams

Commercial readiness extends beyond manufacturing.

Supply planning, regulatory support and operational infrastructure must be prepared ahead of launch.

Leaving these appointments until regulatory approval can create gaps between authorisation and the ability to supply treatment centres effectively.

How Barrington James Supports Cell and Gene Therapy Recruitment

At Barrington James, we work with cell and gene therapy companies to build the specialist teams required throughout the product development lifecycle.

Our Biotechnology Recruitment expertise spans early clinical development, CMC and technical operations, regulatory submissions and commercial manufacturing.

In recent years, we have supported 31 cell and gene therapy companies, helping organisations secure specialist talent from IND through to BLA.

Our experience includes placing a contract technical writing team to support a CAR-T BLA submission for a UK-based commercial-stage business, with the programme subsequently achieving BLA approval.

Our wider experience also includes supporting an emerging cell and gene therapy business with critical regulatory and financial leadership appointments as it prepared for future clinical development.

We support organisations across the US, UK and Europe through permanent, contract and interim recruitment solutions.

By aligning recruitment strategies with programme milestones, we help businesses identify critical hiring requirements before talent shortages become obstacles.

Planning Your Next CGT Hiring Milestone

For cell and gene therapy companies, workforce planning should extend beyond immediate vacancies.

Before your next headcount review, consider five questions:

1. What is our next development milestone, and what comes after it?

2. Which specialist roles will be required, and when does their work need to begin?

3. Which recruitment searches should already be underway?

4. Where could a contract or interim specialist provide short-term support?

5. Which roles may involve extended recruitment processes or notice periods?

The most useful question is not simply when a new employee is needed, but when their work must start and how much time is required to secure the right expertise.

Aligning recruitment with programme development can help CGT companies build the capabilities needed to progress from early clinical studies through regulatory approval and commercial launch.

Alternatively, connect with the Barrington James team to discuss your upcoming hiring requirements and how we can support your next development milestone.

Speak to Our CGT Recruitment Specialists