Experienced Scientist, API Cell Therapy

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:
Rockville, Maryland, United States of America, Spring House, 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 an Experienced Scientist, API Cell Therapy that will be based in Rockville, MD.

Purpose:

The Scientist will reside within the API Cell Therapy group, working independently and in conjunction with the cross-functional (Development and External) teams to support program needs.

This role is responsible for supporting clinical manufacturing of an autologous CAR-T product, including providing guidance to resolve technical issues on the floor and on-call support for Quality to aid in the release of life-saving therapies.

Responsibilities:


* Support clinical ramp-up and manufacturing activities of autologous T-cell derived cell therapy processes to internal and CDMO clinical manufacturing


* Leverage own experience in cell therapy process development to guide resolution for investigations, deviation assessments.

and on-floor support for clinical batches


* Mentor and train team members in manufacturing support, and troubleshooting/investigations; including support for person in plant activities as required


* Drive successful clinical campaigns, write protocols, memos, reports, reviewing/revising batch records to support successful manufacturing with internal and external partners


* Directly support implementation and execution of automated end-to-end manufacturing processes, working directly with CMO and internal resources to ensure successful outcomes.


* Expertise in existing and emerging systems in this space together with troubleshooting is required


* Collaborate with and participate in cross-functional teams to facilitate BLA enabling workstreams


* Identify, critically assess and evaluate opportunities to improve manufactur...