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Associate Scientist, CAR-T Manufacturing (1 of 3)


Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Scientist, 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. 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 Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. The Associate Scientist will join the manufacturing operations team responsible for production of autologous CAR-t products for Phase 1/2a clinical trials. The primary responsibilities for this role are:
  • Provide leadership to the team to perform process unit operations according to standard operating procedures and batch records.
  • Participate in tech transfer of the process from the development lab to cGMP facility, qualification, and validation of the facility and equipment.
  • Draft standard operating procedures and batch records, assist development and management of the training progra
  • Set up process and material flows end to end for the CAR T manufacturing process
  • Work with Process Development team and Quality organization to successfully transfer process to cGMP facility to manufacture products.
  • Participate in set-up of training program for the new hires. Train new employees
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirement, ensuring appropriate environmental control, using proven aseptic skills

Qualifications
  • BS Degree in Biological Sciences or Biochemistry with at least 2 years of relevant experience OR an Associate Degree with at least 4 years for relevant cGMP experience OR high school diploma with at least 6 years of relevant cGMP experience is required
  • Aseptic gowning processing experience in clean room and ISO 5 biosafety cabinets is required
  • Cell expansion using single-use vessels and cell washing processes using automated equipment is required
  • Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products is required
  • Must be able to lift a minimum of 50 lbs and must be able to stand for a long period of time.
  • Must be able to pay attention to details and follow the procedures.
  • Must be comfortable handling human derived materials in BSL-2 containment areas
  • Experience maintaining written records of work in the form of notebooks, technical reports and protocols is required
  • Occasional weekend work is required

Primary Location
United States-Pennsylvania-Spring House
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
9317180418