Senior Director, Analytical Development for our Advanced Therapies Analytical Development
- Leiden, Zuid-Holland
- Vast
- Voltijds
- Leading all aspects of the analytical development function, providing technical and strategic direction aligned with global objectives, regulatory requirements, and scientific best practices.
- Acting as site lead, fostering a collaborative and innovative environment while building a high-performing team focused on analytical excellence to drive initiatives that enhance analytical methodologies, improve efficiency, and ensure robust and scalable processes.
- Serving as the analytical development expert focused on biological assays, method development & validation, and specifications establishment for all cell and gene therapy programs.
- Communicating scientific information to technical and non-technical collaborators, internal and external, ensuring alignment and understanding of analytical development strategies and outcomes for manufacturing and testing.
- Collaborating across R&D functions, including API, DPD, CMC Leaders, discovery, Supply Chain, Quality Assurance, and Global Regulatory Affairs to support product development timelines and objectives.
- Ph.D. or equivalent experience in cell biology, immunology, biological science, or a related subject area with 12+ years experience or an M.S. with 15+ yrs experience.
- Validated expertise in the development of cell and gene therapies with a consistent track record of successful development and regulatory approvals.
- Strong knowledge of regulatory requirements and quality standards and proficient in regulatory submission writing and review.
- In-depth knowledge of the biopharmaceutical industry, with expertise in cell & gene therapies and end to end product development from early dev to commercialization.
- Proven track record in leading scientific teams, with direct and indirect people management experience.
- Exceptional leadership, communication, and interpersonal skills, with the ability to influence and foster collaboration across diverse teams and functions.
- Proven track record of building high-performing teams and managing change in complex and dynamic environments. Proven ability to be self-motivated and make difficult decisions in a timely fashion.
- This role may require up to 25% travel, both domestic and international.