Principal Scientist, Cell Therapy Process Development

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

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 the best Principal Scientist, Cell Therapy Process Development to be in Spring House, PA.

Purpose:

We are seeking an energetic, highly motivated, and creative Principal Scientist to join us in our mission to improve next generation CAR-T cell therapy products for cancer patients within the Cell Therapy Development organization. The ideal candidate has demonstrated expertise in cell therapy process development, particularly late stage (process characterization and validation). In this role, they will design and lead process characterization and optimization studies resulting in the development of new production processes. The successful candidate will work as part of cross-functional teams supporting pre-clinical and clinical programs, focused on CMC development.

You will be responsible for:

• Leverage own experience in cell therapy process development to guide autologous platform and process development efforts focused on patient-derived CAR-T cells

• Design, lead, and execute process characterization studies for autologous CAR‑T manufacturing, including development of study protocols, implementation of DOE/statistical analyses, preparation of comprehensive study reports and risk/impact assessments,

• Mentor and train junior team members on experimental procedures and foster their professional development

• Collaborate with and participate in cross-functional teams to facilitate IND-enabling, clinical Phase I/II-enabling activities as well as BLA enabling workstreams

• Identify, critically assess and evaluate opportunities to improve manufacturing outcomes such as improving success rate, throughput, reducing cost, process time and product quality of the final drug product

• Utilize phase-appropriate process development strategies to identify process parameters and appropriate ranges using QbD principles as applied to cell therapy

• Support successful technology transfer activities, writing protocols, reports, and performing and coordinating activities to support successful manufacturing with internal and external partners

• Communicate program progress and issues to management, stakeholders and to regulatory agencies as necessary.

Qualifications:

• PhD in Immunology, Biological Sciences or Biomedical Engineering with at least 5 years of relevant industry experience (academic experience post-graduate also considered) OR a BS or MS in Biological Sciences, Biomedical Engineering or Immunology with 6-8 years of experience.

• Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required

• Knowledge and experience in autologous CAR-T cell therapy required, together with a demonstrated understanding of T cell biology, and fundamental immunology. Prior hands-on experience with eq