Senior Associate Scientist - CAR-T Automation - Johnson and Johnson
Malvern, PA 19355
About the Job
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.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.
The BioTherapeutics Development and Supply - Analytical Development (BTDS - AD) group is seeking a highly energetic and collaborative Senior Associate Scientist, CAR-T Automation, to join our CAR-T Analytical Development team.
Principal Responsibilities:
- Support method development, qualification, validation and transfer activities.
- Write protocols, reports, and perform and coordinate testing to support manufacturing process development, process validations, and manufacturing investigations.
- Support the automation of in-process and release methods (e.g., cell count, flow cytometry, potency, etc.) for cell therapy programs.
- Maintain laboratory notebooks and prepare written protocols and reports in a Good Manufacturing Practice (GMP) compliant manner.
- Accurately capture data in a timely manner, ensuring data integrity and protocol compliance
- Effectively communicate scientific data and results across technical teams, project teams, and to the health authority as needed.
- Work in a team environment as well as contributing individually to meet project timelines and objectives.
- A minimum of a Bachelor's degree in Biology, Immunology or a related scientific discipline is required. Master's degree in Biology, Immunology or a related scientific discipline is preferred.
- A minimum of 4 years of relevant experience with a Bachelor's degree or a minimum of 2 years of relevant experience with a Master's degree is required.
- Experience with automated cell counters is required.
- Experience with flow cytometry is required.
- Knowledge of basic immunology techniques, including mammalian cell culture, immunofluorescence, ELISA, and PCR, is required.
- Hands-on experience with CAR-T or other cell and gene therapy products is preferred.
- Chemistry, Manufacturing, and Controls (CMC) experience is preferred.
- Experience with the automation of assays is preferred.
- Experience with analytical method development for a variety of cell-based bioassays, binding assays and/or residual impurity assays is preferred.
- Experience working in a current Good Manufacturing Practice (cGMP) environment is preferred.
- Knowledge of potency assays and/or cellular immunology is preferred.
- Must have excellent communication and interpersonal skills.
- Must be detail-oriented with strong organizational skills.
- The ability to work in a cross-functional customer-focused environment is required.
- This position may require up to 10% domestic travel.
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.