Janssen Research & Development, LLC is recruiting for a 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 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.
We are looking for an energetic and highly motivated Scientist candidate with proven 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. S/he will be tasked with integration of new equipment/technologies, unit operation development and route cause investigation, 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 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
- Design and own the execution of phase-appropriate process development studies identifying process parameters and appropriate ranges to be assessed for optimal experimental design of the study
- 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 at least 3 years of relevant industry experience (academic experience post-graduate also considered) (preferred)
- 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) (preferred)
- BS in Biological Sciences, Biomedical Engineering, or Immunology and with at least 8 years of industry experience (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 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
- Experience with cell culture bioreactor operations and process scale up with application to cell therapy
- 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 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
- Deep understanding of biologics industry process development strategies and best practices 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
- Occasional weekend work may be required
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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 .
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.