Sr. Associate Scientist, Analytical Operations - Cell Therapy

职位描述

Kite is seeking a highly motivated individual, with Analytical Development (AD) method and testing experience. Specifically, across multiple testing platforms, including Cytokine Immunoassay, cell-based Potency, Flow Cytometry and PCR-based Molecular Biology. The successful candidate will join the Testing and Logistics (T&L) team, in Analytical Development, and be responsible for testing and releasing of data on defined turn-around times (TAT). This analyst will also be responsible for maintaining inventory and qualification of reagents, as needed. In addition, the staff member will complete Electronic Laboratory Notebook entries and data verification using Good Documentation Practices (GDP). The ideal candidate will be highly motivated and detail-oriented. This role will require reporting on site 3 – 5 days per week.

Responsibilities and Duties

• Responsible for high-volume testing across several Immunoassay, cell-based Potency, Flow Cytometry and PCR-based, Molecular Biology analytical test methods
• Perform data analysis, data review, and data reporting
• Responsible for adhering to Good Documentation Practices (GDP) related to testing documentation and data verification, within a LIMS, to ensure data integrity
• Responsible to attend scheduling meetings, weekly, to understand testing assignments and priorities
• Responsible to learn and gain proficiency on new methods and platforms, according to shifting business needs
• Troubleshooting technical challenges with peers and leadership, in team meetings, as needed
• Perform laboratory duties to support maintenance of laboratory cleanliness, order, inventory and 5S practices
• Perform some critical reagent preparation and qualification procedures
• Track inventory of critical reagents needed to sustain high-volume testing

• Write, review and edit technical documents, including SOPs, Memorandums, protocols, and reports, as required
• Support the maintenance and calibration of laboratory instruments (e.g. CytoFLEX, Tecan, ddPCR etc.)
• Additional responsibilities may be assigned, to reflect changes in business processes/needs

Requirements

• MS degree in the field of Biological Sciences, or related field, with 3+ years of experience OR
• BA or BS degree in the field of Biological Sciences, or related field, with 5+ years of experience

Additional Qualifications

• 4+ years of Immunoassay, Flow Cytometry (including 3+ color Flow Cytometry), ELISA, Cell Culture and PCR experience, in academia or industry
• Technical expertise in analytical instrument, troubleshooting, and proficiency with flow cytometry software (e.g., FlowJo, FACSDiva, CytExpert, FACS Express)
• Previous experience with cell therapy products, is a plus
• Proficiency with using Microsoft Office (Word, Excel, PowerPoint)
• Experience with JMP statistical software, is a plus
• Proficiency with Smartsheet, is a plus
• Excellent organization and communication skills, as well as strong problem solving and analytical skills, and the ability to work in a cross-functional/matrix environment