Senior Scientist, External Manufacturing MS&T (CAR-T)

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:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, 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 Senior Scientist, External Manufacturing MS&T (CAR-T) to be in Raritan, NJ.

Purpose:

The Senior Scientist, External Manufacturing MS&T (CAR-T) supports manufacturing activities for the Advanced Therapies Supply Chain organization within the third-party manufacturing site. This includes executing robust strategies to maintain the validated state of cell and gene therapy processes while implementing lifecycle management initiatives related to new technologies, automation, technology transfer, etc.  This role serves as a person-in-plant in support of routine manufacturing, aids in change management activities at the third-party manufacturing site and supports complex deviations. This is a critical role supporting the site’s technical, supply, and compliance related objectives. This position supports/participates in the virtual plant team and actively collaborates with Quality, Supply Chain, and Growth & Partnerships functions.

You will be responsible for:

• Provide manufacturing floor support, investigations of major/critical process deviations, impact assessments, process monitoring/continued process verification, and process improvement projects.

• Act as receiving site for any lifecycle process technology transfers including process qualification/comparability campaigns, process risk assessments, process control strategies and new process training.

• Provide technical support to regulatory filings, regulatory inspections, and health authority questions.

• In collaboration with other functions, supports the development and implementation of fit-for-purpose effective systems and business processes to assure compliance with corporate guidelines for deviation investigations, technology transfer, process monitoring, and other relevant areas.

• Support process monitoring and process data analysis, troubleshooting, facility fit assessments of new processes into the existing manufacturing plant, assessments and writing of technical documents and technical optimization/implementation projects

• Translate strategic product roadmaps to detailed execution plans for programs to deliver on target outcomes to enhance the lifecycle of the product.

• Drive continuous improvement and foster an operational excellence culture to enhance productivity and efficiency of operations

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QUALIFICATIONS:

• A Bachelor’s Degree or Master’s Degree in Science/Engineering or Equivalent with 4-6 years of Biotech/ Pharmaceutical experience or equivalent industry experience.

• Prior work experience in a manufacturing environment

• Knowledge of good manufacturing practices (GMP) and documentation.

• Ability to work in a cleanroom, laboratory, and office setting,

• Excellent judgment. able to prioritize and decide appropriate courses of actions.

• Effective at implementing decisions, troubleshooting and problem-solving skills in a fast-paced environment.

• Hands-on experience and knowledge in manufacturing sciences and operations support, technology transfer, process comparability process monitoring, change management, cGMP compliance, and advanced therapies (i.e. cell/gene therapy products, vaccines) product regulatory and validation requi