Principal Scientist, Cell Therapy Process Development Full-time

Principal Scientist, Cell Therapy Process Development

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 equipment and unit operations typically used in process development and manufacture of cell therapy products is required
• Experience with cell culture bioreactor operations and process scale up with application to cell therapy is required; expertise in gene editing using lentiviral vector, flow cytometry and potency assays is advantageous
• Proven leadership skills and problem-solving experience in cell therapy industry with an emphasis on pipeline projects
• Deep understanding of biologics industry process development strategies and best practices as applied from early development to late stage and commercialization
• Must be detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data. Must have excellent communication, interpersonal and collaborative skills
• Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic. Highly adaptable and responsive, and committed to completing tasks in a timely fashion
• Occasional weekend work may be required.
• This role may require up to 10% travel as needed.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.