Distinguished Scientist, Large Molecule Biologics

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:
Spring House, Pennsylvania, United States of America, US004 PA Malvern - 200 Great Valley Pkwy

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 Distinguished Scientist, Large Molecule Biologics to be in Malvern, PA or Spring House, PA.

Purpose:

Within the CMC group, you will lead multiple CMC Teams spanning from pre-NME through post-Approval, including Life Cycle Management (LCM).

This includes, but is not limited to, the creation and implementation of the development strategy, the adherence to the CMC 12 Stage process, approval by governance bodies, the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and timelines, and the delivery of clinical and launch drug supplies in accordance with development plans.

You will be the CMC point of contact with the Compound Development Team(s) (CDT) and Value Stream Teams (VST).

You will be responsible for:


* seeing opportunities for team or product development improvements across the TDS organization.

They may also support or lead teams in implementing initiatives to deliver organizational or process improvements.


* demonstrating behaviors consistent with the current Leadership Imperatives and will be mentoring and coaching CMC Team Members to improve their skills and contributions to the organization in collaboration with line management.


* focusing on development projects which may span multiple Therapeutic Areas (TAs) and/or Innovative Medicine Supply Chain (IMSC) and stages of development.


* Working in a multi-disciplinary, complex and innovative environment, with evidence of delivering results in this setting, including: In-depth experience and technical knowledge of the Large Molecule CMC protein and Bioconjugates (include Antibody Drug Conjugat...