Johnson & Johnson is recruiting for a Principal Scientist, CAR-T Process Development based in Spring House, PA.
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We are looking for an energetic, highly-motivated and collaborative Principal Scientist candidate with demonstrated expertise in cell therapy process development and process innovation. In this role, the successful candidate will be involved in process design, unit operation development, and parameter optimization studies resulting in the development of new production processes. The successful candidate will work as part of a cross-functional teams supporting pre-clinical and clinical programs, focused on autologous processes.
Primary responsibilities for this role include but are not limited to:
- Design and execute process development studies using sound scientific and engineering principles to develop and improve unit operations used for production of autologous T-cell therapies,
- 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.
- Lead/contribute to the design and execution of phase-appropriate process development study plans, identifying process parameters and appropriate ranges to be assessed for optimal experimental design of the study.
- Investigate improvements to current processes used for T-cell selection, activation, transduction and expansion together with their impact on critical quality attributes.
- Work in a team and matrix environment as well as contribute individually to meet project timelines and deliverables
- Provide technical leadership and train end-users and more junior team members on activities
- Timely and thorough documentation and completion of electronic laboratory notebooks.
- Author reports detailing experimental work and summarizing results, protocols, technical reports and SOPs.
- Support technology transfer activities, writing protocols, reports, and performing and coordinating activities to support successful manufacturing
- Maintain all individual training and safety requirements and participate in routine lab operations (maintenance, safety activities, calibrations)
- Participate in routine lab operations (lab maintenance, safety inspections, etc) and maintain compliance with all appropriate SOPs for laboratory work, data recording, and laboratory equipment
- Other duties, as necessary