Janssen Research & Development, LLC. is recruiting for a Senior Associate Scientist to join a growing team focused on cell therapy process development for the development of innovative treatments for cancer in Spring House, PA or Raritan, NJ. The position is a key part of the growing API Cell and Gene Therapy Organization. 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 and Development, LLC. is part of the Janssen Pharmaceutical Companies. We are seeking energetic and highly motivated talent with demonstrated expertise in autologous cell therapy process development. This position focuses 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. The role will support the 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 Sr. Associate Scientist works as part of a cross-functional team supporting clinical programs and commercial production, with a focus on CMC development. Key Responsibilities:

• Leverage 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 as necessary, and at national conferences as appropriate
• Other duties, as necessary

QUALIFICATIONS Education:

• BS in Biological Sciences, Biomedical Engineering, or Immunology with at least 6 years of relevant industry experience (required)
• MS in Biological Sciences, in Biological Sciences, Biomedical Engineering or Immunology with at least 3 years of industry experience (relevant academic experience also considered) (preferred)

Experience And Skills: Required:

• Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes
• Experience with cell culture bioreactor operations and process scale up with application to cell therapy, expertise in gene editing, flow cytometry and potency assays
• Must be detail-oriented, highly organized, and able to manage multiple tasks, handle strict 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

Preferred:

• Knowledge and experience in autologous CAR-T cell therapy required, together with a proven 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
• Exposure to and knowledge of GMP manufacturing
• 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

Other:

• 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. 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. PRIMARY LOCATION United States-Pennsylvania-Spring House-Welsh & McKean Roads OTHER LOCATIONS North America-United States-New Jersey-Raritan ORGANIZATION Janssen Research & Development, LLC (6084) JOB FUNCTION R&D REQUISITION ID 2206067209W

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