Scientist, Cell Therapy Process Development

描述

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientist to join a growing team focused on cell therapy process development 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. 

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.  We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.  Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.

We are looking for an energetic, highly-motivated and collaborative 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

資格

Education:

• PhD in Biological Sciences, Biomedical Engineering or Immunology with at least 2 years of relevant industry experience OR MS in Biological Sciences, Biomedical Engineering or Immunology and with at least 6 years of relevant industry experience OR a BS in Biological Sciences, Biomedical Engineering or Immunology and with at least 8 years of relevant industry experience is required.  Directly relevant academic experience in CAR-T development will also be considered as appropriate.

Experience and Skills:

• 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

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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 .

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.

ERADICATECANCER