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Associate Director - Quality & Technical Operations Europe
Senior Director of Production
A clinical-stage biopharmaceutical company developing next-generation Advanced Therapy Medicinal Products (ATMPs) is searching for a new Senior Director of Production. With a growing portfolio of innovative assets in Phase I to III trials, they are establishing a world-class GMP production capability to support their clinical and future commercial ambitions.
Position Overview
The Senior Director of Production will lead and manage GMP manufacturing operations for their Phase I–III clinical ATMP programs. This role is critical in ensuring robust, compliant, and timely manufacturing of their therapy products. You will bring strong leadership experience, hands-on knowledge of ATMP production processes, and a solid understanding of the unique challenges of early clinical-stage manufacturing.
Key Responsibilities
* Lead and manage all day-to-day Production operations of the GMP manufacturing facility for clinical ATMP products
* Oversee Production processes in accordance with EU and FDA GMP regulations
* Build and manage a multidisciplinary team of Production staff (Managers, Team Leads, Technicians, Specialists) across Fill/finish operations and Aseptic Processes
* Develop and maintain production schedules to meet clinical trial supply timelines and regulatory requirements
* Drive compliance with cGMP in accordance with Germ Drug Law sections 12 & 13 and ATMP-specific regulations; ensure readiness for audits and inspections
* Partner closely with QA, QC, MSAT, Regulatory Affairs, and Process Development to support batch release, deviation management, and process improvements
* Implement process controls and drive continuous improvement initiatives in a clinical-stage environment
Required Qualifications
* BSc/MSc in Biotechnology, Bioprocess Engineering, Pharmacy, or related life sciences
* 10 - 15+ years of GMP experience in biopharmaceutical manufacturing, including extensive years at leadership
* Hands-on experience in clinical-stage ATMP production
* In-depth knowledge of GMP requirements for clinical trial material (EU/FDA Phase I–III), including aseptic operations and contamination control
* Proven success leading manufacturing teams and managing multiple concurrent clinical programs
* Strong organizational, communication, and decision-making skills in a high-paced environment
Remuneration
* Base Salary: €160,000 - €200,000 fixed per annum (depending on experience)
* Annual Bonus: 10%
* Long-term Incentives
* Relocation support
If you are interested, click apply or send a direct application to matt.lancaster@discoverinternational.com.
Seniority level
* Director
Employment type
* Full-time
Job function
* Manufacturing and Production
Industries
* Pharmaceutical Manufacturing and Biotechnology Research
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