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Ref No.: 20-00406
Location: Summit, New Jersey

This position is for a Cell Therapy Potency Leader. The role will design, perform, and interpret experiments, with minimal supervision, to support analytical development objectives as part of an analytical development team. Ensure smooth day-to-day operation of the Analytical Laboratory.

Responsibilities will include, but are not limited to, the following:

With minimal supervision, design and execute/implement analytical experiments of significant complexity. Provide analytical support and guidance to process development and characterization groups. Conduct experiments/analysis independently and assist other scientists/analysts with experiments employing various methodologies, including: cell culture, flow cytometry, ELISA, cell counting, microscopy, etc.Critically analyze and interpret assay protocols and suggest improvements.Apply fundamental scientific knowledge to projects and problems in a positive manner. Perform data analysis and summarize experimental results. Interact with Quality Control and Process Development teams to advance analytical projects. Organize, record and maintain experimental data. Convey data analysis and interpretation to supervisor, colleagues, and other groups with clarity and high level of accuracy. Ensure proper operation and perform routine maintenance of all laboratory equipment. Assist other staff to complete all laboratory tasks as necessary Document/review laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with GLP/GDP requirements. Train new members of department in basic flow cytometry techniques and instrumentation. Maintain a safe workplace in accordance with company and OSHA policies/procedures.

Skills/Knowledge Required:

  • M.S. in Biology or related discipline with 3+ years of relevant experience or PhD in Biology or related discipline with 0+ years of relevant experience
  • Must have excellent organization skills and ability to handle multiple tasks
  • Highly motivated, willingness to acquire new skills and ability to work with minimal supervision
  • Must have strong scientific knowledge appropriate for analytical development work
  • Experience in diverse analytical techniques (ELISA, flow cytometry) would be advantageous
  • Experience in working with healthy authority regulations (ICH, FDA, EMEA, etc) would be advantageous
  • Experience working in a regulated environment would be advantageous
  • Excellent verbal and written communication skills

Client recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.