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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 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.
Janssen Biotherapeutics Development & Supply is seeking an energetic and highly motivated individual with proven expertise in CAR-T process development to join our Cell Therapy Process Development team as a Senior Scientist. In this role, they will focus on process development, characterization, and validation activities, enabling the advancement of these breakthrough treatments for hematological and solid tumor malignancies. They will work as part of cross-functional teams supporting pre-clinical, clinical, and commercial programs, focused on autologous processes.
Responsibilities of the Senior Scientist may include, but are not limited to, the following:
Key Responsibilities:
- Use own experience in cell therapy process development to guide CAR-T autologous platform and process development efforts
- 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 cultivate their professional development
- Proactively mitigate potential conflicts and rapidly resolve communication problems with internal partners, cross-functional teams and third-party collaborators
- 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
- 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
- Cultivate a working environment that encourages the company's commitment to equal employment opportunity and the value of a diverse work force
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Education:
PhD in biology, immunology, engineering, or other relevant scientific field with at least 5 years of relevant industry experience (academic experience post-graduate also considered) OR MS with at least 8 years of industry experience (relevant academic experience also considered) OR a BS 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 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 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 and flow cytometry analysis 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
- Meticulous, 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
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 .
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