Site Leader (Senior Director / VP) – mRNA/LNP CDMO

CDC General Solutions is partnering with a growing CDMO specialising in nucleic acid and advanced therapy manufacturing, including DNA, RNA and mRNA/LNP. Following continued investment, the company is appointing a Site Leader to drive operational execution as it scales.

Reporting to the Chief Business Officer, the Site Leader will run day-to-day operations at the Bilbao site, with responsibility for manufacturing, quality control, supply chain and facilities. You'll turn executive direction into clear operating plans, lead and develop site teams, and make sure all activity meets GMP, safety and customer commitments.

This is a hands-on operational leadership role. Enterprise strategy, commercial ownership and P&L; sit with the executive team.

Key responsibilities

- Lead site-wide execution across manufacturing, QC, supply chain and facilities, setting priorities and making ownership clear
- Turn executive direction into operating plans, milestones and resourcing decisions
- Coordinate production schedules, materials, staffing, testing and equipment readiness to meet customer timelines
- Run a practical management cadence covering KPIs, risk escalation and issue resolution, without unnecessary bureaucracy
- Oversee GMP manufacturing readiness and execution for DNA, mRNA, saRNA and LNP programmes
- Provide site-level oversight of technology transfer, scale-up, qualification and validation readiness, partnering with MSAT, Process Development, Engineering and Quality
- Make sure technical teams have clear priorities and resources for mRNA production, purification and LNP formulation
- Drive robust,



reproducible processes and continuous improvement
- Partner with QA on GMP compliance, inspection readiness, data integrity, deviations, CAPA and change control
- Oversee EHS, facility and equipment availability, and preventive maintenance
- Manage site expenditure, capacity planning and capital projects within approved budgets
- Lead, coach and develop site managers and multidisciplinary teams, with a visible, hands-on presence on the manufacturing floor
- Work effectively across site functions and corporate matrix teams
- Partner with commercial leadership to align demand with capacity and deliver customer commitments
- Support customer-facing technical discussions and external technology transfers
- Escalate material risks to quality, safety, capacity or delivery promptly, with clear recommendations

Requirements

- 10-15 years in pharmaceutical, biotech or CDMO operations, including 5 years leading manufacturing teams or multiple operational functions
- Proven GMP manufacturing leadership, including exposure to QC, supply chain and facilities
- Strong knowledge of pharmaceutical quality systems, technology transfer, scale-up and site readiness
- Experience in biologics, nucleic acids, mRNA/LNP or advanced therapies preferred; direct LNP experience is highly valued
- Familiarity with process validation, investigations, qualification and analytical controls is advantageous
- Degree in engineering, biotechnology, life sciences, pharmaceutical sciences or a related field
- Fluent Spanish and professional English; experience leading teams in Spain strongly preferred

Apply via LinkedIn or contact Harriet Wheat directly at [email protected]

📌 Site Lead (País Vasco)
🏢 CDC Global Solutions
📍 País Vasco