Descrizione
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 directly supporting technology transfer of autologous cell therapy processes to internal clinical manufacturing, as well as to contract manufacturers in support of pipeline programs. The successful candidate will also directly interact with both new and existing partners to support the development, implementation and troubleshooting of end-to-end automation systems and approaches for autologous T-cell therapeutics. 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:
- Support technology transfer of autologous T-cell derived cell therapies processes to internal and CDMO clinical manufacturing
- Leverage own experience in cell therapy process development to guide autologous platform and process development efforts focused on T-cell derived effector cells
- As a leader; mentor and train team members on technology transfer, manufacturing support and troubleshooting/investigations; including support for person in plant activities as required
- Drive successful technology transfer activities, writing protocols, reports, and performing and coordinating activities to support successful manufacturing with internal and external partners
- Directly support implementation and execution of automated end-to-end manufacturing processes, working directly with equipment vendors and internal resources to ensure successful outcomes. Expertise with existing and emerging systems in this space together with troubleshooting is required
- 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
- Communicate program progress and issues to management, to regulatory agencies as necessary, and at national conferences as appropriate
- Other duties, as necessary
Qualifiche
Education:
- 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 manufacturing and technology transfer is required
- Prior hands-on experience with automation equipment and end-to-end systems is required; expertise in their operations in both process development and manufacturing environments for cell therapies is highly advantageous
- S/he 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
- Proven leadership skills and problem-solving experience in cell therapy industry with an emphasis on technology transfer and end-to-end automation is required
- Occasional weekend work may be required; travel to support technology transfer and person in plant activities will 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.
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