Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist to join a growing team focused on cell therapy process development for the development of innovative treatments for cancer. The position is a key part of the growing API Cell and Gene Therapy Organization located in Spring House, PA site.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are looking for an energetic and highly-motivated Senior Scientist candidate with demonstrated expertise in autologous cell therapy process development, with an emphasis on CAR-T modified immune effector cell products. The successful candidate will focus on the development of the next generation of autologous cell therapies with an emphasis on their rapid implementation for clinical and in time commercial products, enabling the advancement of these breakthrough treatments for hematological and solid tumor malignancies. S/he will be tasked with integration of new equipment/technologies, unit operation development and end-to-end process development, resulting in transformative manufacturing processes with enabling COGs ranges for cGMP Manufacturing.
The successful candidate will work as part of a cross-functional team supporting pre-clinical and clinical programs, focused on CMC development. Primary responsibilities for this role include, but are not limited to:
- Leverage own experience in cell therapy process development to guide autologous platform and process development efforts focused on T-cell derived effector cells
- Develop future autologous cell therapy pipeline processes, keeping the requirements of clinical and commercial manufacturing in mind
- Design and lead the execution of phase-appropriate process development studies identifying process parameters and appropriate ranges to be assessed for optimal experimental design of the study
- As a group lead, mentor and train 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
- Drive 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, to regulatory agencies as necessary, and at national conferences as appropriate
- Other duties, as necessary
- PhD in Immunology, Biological Sciences or Biomedical Engineering with at least 5 years of relevant industry experience (academic experience post-graduate also considered) OR MS in Biological Sciences, in Biological Sciences, Biomedical Engineering or Immunology and with at least 8 years of industry experience (relevant academic experience also considered) OR a BS in Biological Sciences, Biomedical Engineering or Immunology and with at least 10 years of industry experience is required
Experience and Skills:
- 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.
- Exposure to and knowledge of allogeneic cell therapy and iPSC/stem cells is advantageous
- Experience with cell culture bioreactor operations and process scale up with application to cell therapy is required; expertise in gene editing, 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
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.