Sr Dir Biotherapeutics RD

ry & Pre-Clinical/Clinical Development
Job Sub Function:
Biotherapeutics R&D
Job Category:
People Leader
All Job Posting Locations:
Leiden, South Holland, Netherlands
Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://https://www.jnj.com/innovative-medicine

We are searching for the best talent for Senior Director Analytical Development for our Advanced Therapies Analytical Development (AD) organization within Therapeutics Development and Supply to be based in Leiden, Netherlands.

Purpose: In this leadership role, you will guide a dedicated team of over 50+ scientists, providing strategic and scientific direction for the analytical development of all advanced therapy programs, including cell and gene therapies from new molecular entity through to commercial licensure.

You will be responsible for**:**

• 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.

Qualifications / Requirements:

• 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.

#Li-Hybrid