Principal Scientist, 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:
Malvern, Pennsylvania, United States of America

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

We are searching for the best talent for a Principal Scientist, CAR-T Analytical Scientific Integrator – Advanced Therapies to be in Malvern, PA.

Purpose: The Principal Scientist, 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 the output and quality for technical reports and regulatory documentation through the writing of technical analytical content for regulatory submission and provide strategy to meet regional customer requirements in the U.S., EMEA and Asia Pac.

You will be responsible for:


* Provide strategic and technical leadership in analytical development and lead a cross-functional scientific team consisting of members from each of the Analytical Development (AD) sub-functions.


* Represent AD on the CMC team and accountable for all AD project deliverables.


* Coordinate the execution of cross-site, cross-functional analytical deliverables, for method development, process scale-up and tech transfer, through commercialization.


* Accountable for project risk management, including creation of the risk register, developing appropriate risk mitigation strategies and heightened concerns.


* Collaborate with various partners outside of DPDS, including Commercial Manufacturing, Regulatory, Quality, Discovery and external partners.


* Lead the execution of critical quality attribute (CQA) assessment, analytical control strategy, and product specifications for programs.


* Lead the analytical review of programs at governance meetings with support from subject matter experts.


* Accountable for submission of complete, consistent, and high...