Associate Director, CAR-T Analytical Scientific Integrator – Advanced Therapies

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Biotherapeutics R&D

Job Category:
Scientific/Technology

All Job Posting Locations:
Leiden, South Holland, Netherlands

Job Description:

About Innovative Medicine

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://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country (s) that align with your preferred location (s):

United States – Requisition Number: R-018519

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for an Associate Director, CAR-T Analytical Scientific Integrator - Advanced Therapies to be located in Malvern, PA or Leiden, Netherlands.

Purpose: The Associate Director, CAR-T Analytical Scientific Integrator will provide analytical, technical and strategic leadership to a matrixed team, in addition to representing Advanced Therapy (BioTD-AD) on the CMC team(s).

This role is also responsible for working with teams in the preparation of technical documents and regulatory submissions, participating in review, and contributing to development of strategies to follow global requirements.

You will be responsible for:



* Representing analytical development to provide strategic and scientific guidance to CMC project teams for all analytical topics including method development, control strategy and regulatory filings supporting FIH through commercial licensure.
 


* Leading the development and execution of analytical strategy, including shaping the strategy to meet global health authority expectations.
 


* Leading the analytical review of each program at governance meetings with support from subject matter experts.
 


* Ensuring the submission of complete, consistent, comprehensive, high-quality dossiers.
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