Scientist, Cell Therapy Process Development

Johnson & Johnson is recruiting for a Scientist, Cell Therapy Process Development to join a growing team passionate about autologous cell therapy 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 Janssen, we never stop working toward a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension. Visit us: www.janssen.com.

• Independently lead and manage process development studies using sound scientific and engineering principles to develop and improve end-to-end operations used for production of autologous T-cell therapies.
• Lead phase-appropriate process development studies, identifying the process parameters and appropriate ranges that require assessment.
• Collaborate with and participate in cross-functional teams to facilitate IND, clinical Phase I/II, and BLA-enabling workstreams along with authoring regulatory sections and supporting reports.
• Communicate results in writing and oral presentations to enable key decision-making.
• Work as a key team member on shared deliverables to meet project timelines.
• Timely and detailed documentation and completion of electronic laboratory notebooks
• Cultivate a working environment that encourages the company's commitment to equal employment opportunity and the value of a diverse work force.

• • PhD degree with at least 1 year of post-doctoral and/or relevant industry experience in Biomedical/Chemical Engineering, Immunology, Biological Sciences or a related field is highly preferred; OR a Master's Degree and at least 5 years of experience performing progressively advanced duties at the Senior Associate Scientist level; OR a minimum of 8 years of industry experience performing progressively advanced duties beyond a B.S. degree, is required.
• Strong foundation in biology/immunology/biochemistry as applied in cell and gene therapy processes (such as aseptic cell culture, cellular metabolism, T-cell biology, cryopreservation) is required.
• Hands-on experience in CAR-T cell therapy, T cell biology, or fundamental immunology is required.
• Prior hands-on experience with equipment and unit operations typically used in process development and manufacture of cell therapy products is preferred.
• Experience with late-stage cell therapy process development (process characterization, authoring regulatory filing sections) is preferred.
• Ability to work independently and lead multiple projects and workstreams simultaneously.
• Able to independently complete and troubleshoot experiments, analyze/ report/present data and collaborate with team members to design studies.
• Able to manage time and elevate relevant issues to other team members.
• Detail oriented with excellent verbal and written communication skills.
• Excellent problem-solving skills as applied to process and equipment troubleshooting.
• Solid understanding of statistical software (e.g. JMP) is preferred
• Must be comfortable handling and processing blood or serum samples is required.
• 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.
• This role is based in Spring House, PA and may require occasional weekend work.