Janssen Research & Development, LLC is recruiting for a Scientist, CAR-T Process Development located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Scientist, CAR-T Process Development will be a part of 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.
We are looking for an energetic and highly motivated Scientist candidate with demonstrated expertise in autologous cell therapy process development. The successful candidate will focus on the late-stage process development of autologous cell therapies with an emphasis on process improvement, life-cycle management, and tech transfer, enabling the advancement of these breakthrough treatments for hematological and solid tumor malignancies. You will be tasked with integration of new equipment/technologies, unit operation development and route cause investigation, resulting in ground-breaking manufacturing processes with enabling COGs ranges for cGMP Manufacturing. You will work as part of a cross-functional team supporting clinical programs and commercial production, focused on CMC development.
- Use own experience in cell therapy process development to guide autologous platform and process development efforts
- Lead, design, and execute phase-appropriate process development studies to generate data to support development activities
- Collaborate with and participate in cross-functional teams to facilitate BLA enabling workstreams, BLA submission, commercial launching, and post-approval activities
- Identify, critically assess, and evaluate opportunities to improve manufacturing outcomes such as improving process robustness, manufacturing successful rate, product quality of final product, and reducing COGs
- Apply 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 and at national conferences, if needed
- Other duties, if needed
- PhD in Immunology, Biological Sciences or Biomedical Engineering with 2-3 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 5 years of industry experience (relevant academic experience also considered) OR a BS in Biological Sciences, Biomedical Engineering or Immunology and with at least 8 years of industry experience is required.
Experience And Skills:
- Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes
- 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 working experience with T cells, and with equipment and unit operations typically used in process development and manufacture of cell therapy products
- Must be able to work with lentiviral and BSL-2 materials
- Experience with cell culture bioreactor operations and process scale up with application to cell therapy
- Proficient in analysis of large data sets using Minitab and JMP or equivalent software
- Deep understanding of biologics industry process development strategies and standard methodologies as applied from early development to late stage and commercialization
- Exposure to and knowledge of GMP manufacturing
- Expertise in gene editing, flow cytometry and potency assays
- Problem-solving experience in cell therapy industry with an emphasis on pipeline projects
- 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
- Must be diligent, highly organized, and able to lead multiple tasks, handle timelines and deliver quality data
- Must have excellent communication, interpersonal and collaborative skills
- Occasional weekend work may be required
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .