Job Title: Director of Clinical Production – Biologics (Advanced Therapies)
Location: Frankfurt
Department: Clinical Manufacturing / GMP Operations
Reports To: VP Manufacturing / Site Head
Type: Full-time
Position Summary:
We are seeking a dynamic and experienced Director of Clinical Production to lead the end-to-end GMP manufacturing of advanced biologic therapies. This role is critical to scaling clinical production capabilities in compliance with global regulatory standards while driving innovation, digitalization, and operational excellence.
You will oversee cross-functional GMP teams, manage clinical supply strategies, and guide tech transfer, validation, and regulatory readiness activities. This is a high-impact leadership role for someone passionate about delivering next-generation therapies to patients.
Key Responsibilities:
* Lead and manage clinical GMP manufacturing of advanced therapies (ATMP)
* Provide strategic oversight for multiple production units (e.g., upstream, downstream, aseptic filling, viral vector suites, buffer/media prep)
* Ensure all clinical batches are manufactured in accordance with EU/FDA GMP, ICH, and internal quality standards
* Oversee tech transfer of new products/processes from Development into GMP manufacturing
* Partner with QA/QC, Process Development, Regulatory Affairs, and Supply Chain to support clinical trial readiness and global submissions (IMPD, IND, BLA, MAA)
* Lead capacity planning, resource allocation, and continuous improvement initiatives (e.g., Lean, MES/Digitalization)
* Support construction, commissioning, and qualification of new cleanrooms and equipment for expanded capabilities
* Build and mentor a high-performing team, fostering a culture of compliance, collaboration, and innovation
Qualifications:
* Master’s or PhD in Biotechnology, Bioprocess Engineering, Pharmacy, or related field
* 10+ years in clinical or commercial biologics manufacturing, with at least 5 years in a senior GMP leadership role
* Proven expertise in ATMPs, viral vectors, or recombinant biologics under GMP
* Strong understanding of regulatory filings (Module 3, IMPD, BLA, MAA) and tech transfer
* Experience in building and scaling manufacturing capabilities, including facility design and qualification
* Leadership in cross-functional environments with QA, Regulatory, Process Development, and Engineering
* Knowledge of MES and digital manufacturing tools is a plus
* Fluency in German & English
Why Join Us?
* Drive the future of clinical manufacturing in a fast-paced, innovation-driven environment
* Contribute to life-changing therapies in oncology, rare disease, and regenerative medicine
* Collaborate with global teams committed to scientific excellence and patient impact