We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

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

Qualifications

• PhD in Biological Sciences, Biomedical Engineering or Immunology with at least 6 years of relevant industry experience OR MS in Biological Sciences, Biomedical Engineering or Immunology and with at least 9 years of relevant industry experience OR a BS in Biological Sciences, Biomedical Engineering or Immunology and with at least 11 years of relevant industry experience is required (Directly relevant academic experience in CAR-T development will also be considered as appropriate).

• Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes (such as aseptic, cell culture, cellular metabolism, T-cell biology, cryopreservation) is required

• Knowledge and experience in CAR-T cell therapy, T cell biology, and fundamental immunology. Prior hands-on experience with equipment and unit operations typically used in process development and manufacture of cell therapy products is required

• Understanding of cGMP manufacturing of biological products is preferred, with an emphasis on translating unit operations into implementable manufacturing processes

• Independently as well as collaboratively design, execute and troubleshoot experiments, analyze, report and present data

• Experience working in a self-driven, performance/results oriented, fast paced environment

• Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects

• Able to creatively manage time and elevate relevant issues to project lead.

• Strong scientific and technical writing and presentations is required

• Familiarity with engineering principles and statistical analysis, including design of experiments (DOE).

• Detail oriented with excellent verbal and written communication skills

• Excellent problem-solving skills

• Working knowledge of statistical software (e.g. JMP) is preferred

• Must be comfortable handling and processing blood or serum samples

• Occasional weekend work may be required

• This role is based in Spring House, PA and may require up to 10% 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, 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.careers.jnj.com.