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.
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We are looking for an energetic, highly motivated and creative Scientist to join us in our mission to improve next generation CAR T cell therapy products for cancer patients.
The candidate has demonstrated expertise in cell therapy process development and process innovation.
In this role, they will focus on process design, automation, unit operation development, and parameter optimization studies resulting in the development of new production processes.
The successful candidate will work as part of cross-functional teams supporting pre-clinical and clinical programs, focused on autologous processes.
Primary responsibilities for this role include but are not limited to.
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.
Qualifications ·      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.
.
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.
.
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.
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, disability, 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.
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