Technical Fellow (Director), Advanced Therapies - MSAT

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:

People Leader

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 Technical Fellow (Director), Advanced Therapies -MSAT to be in Raritan, NJ, Titusville, NJ, Horsham, PA, or Spring House, PA.

Purpose:

The Technical Fellow serves as a subject matter expert (SME) in CAR-T manufacturing and Quality Control analysis, playing a pivotal role in ensuring the quality and safety of cellular therapies. This position is critical in addressing challenges that arise when non-conforming products or deviations are generated during the manufacturing process, which can impact patient treatment. The Technical Fellow actively engages with healthcare providers to navigate these challenges, facilitating clear communication and collaborative problem-solving.

In addition to direct interaction with healthcare providers, the Technical Fellow curates and analyzes manufacturing case studies to expedite the release of drug products. This role requires deep expertise in key areas, including apheresis collection, cryopreservation, cell processing, quality control testing, and quality release processes. The Technical Fellow provides insights to both internal manufacturing teams and external partners, ensuring adherence to the highest standards of quality.

The Technical Fellow is also an integral member of various site/network operational teams, including planning, release, clinical/commercial rapid response teams, safety management, and site escalations. In this capacity, they contribute to the development of robust strategies that maintain the validated state of cell therapy processes while supporting lifecycle management initiatives involving new technologies, automation, and technology transfer.

Finally, this role serves as a key thought leader and scientific expert driving manufacturing trend investigation teams towards root cause identification.  Proactively identifying complex scientific correlations linking deep univariate and multivariate data analyses to T-cell biology fundamentals, these role partners with development and site technical operations teams to drive towards robust conclusions.  Through successful investigation, complex trends can be addressed by reducing non-conformance rates, aiding patients in need of rapid treatment.

This position is essential for enabling the CARVYKTI network's technical, supply chain, and compliance-related objectives. Collaborating across a complex network of internal and external stakeholders, this role drives improvements in patient care and enhances the overall efficiency of CAR-T therapy delivery.

You will be responsible for:

• Provide deep subject matter expertise to batch advocacy efforts for non-conforming products, leading manufacturing trend investigations and supporting root cause identification

• Engage with key opinion leaders in cell therapy space, academics, physicians, hospital/medical centers lead to drive down patient related contributions to non-conforming product.  Engage with new markets to set up for success during the initial launch period (aiding in education on patient factors/contributions to manufacturing success)

• Provide deep subject matter expertise on initiatives aimed at reducing non-conforming product rates, through projects that may/may not require regulatory approval

• Provide technical support to regulatory filings, regulatory inspections, and he