Quality Control - Flow Cytometry Lead Scientist

Memphis, TN

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There’s a reason St. Jude Children’s Research Hospital is consistently ranked on Fortune Magazine’s “100 Best Places to Work For” list. Because at our world-class pediatric research hospital, every one of our professionals shares our commitment to make a difference in the lives of the children we serve. There’s a unique bond when you’re part of a team that gives their all to advance the treatments and cures of pediatric catastrophic diseases. The result is a collaborative, positive environment where everyone, regardless of their role, receives the resources, support and encouragement to advance and grow their careers and be the force behind the cures.

Quality Control - Flow Cytometry Lead Scientist

We are looking for an innovative Lead Scientist to join the Children’s GMP, LLC (CGL) Quality Control Department and oversee the operations and supervise the staff of the Quality Control (QC) Flow Cytometry Laboratory (FCL), and guide Quality Control Flow Cytometry personnel in their daily tasks and projects.

The Lead Scientist will work with Principal Investigators, Experimental Cellular Therapy Laboratory (ECTL), Human Application Laboratory (HAL) and the current Good Manufacturing Practice (cGMP) cellular therapy manufacturing group on the development, transfer, assay validation, and implementation of flow cytometry assays for in-process and release testing of cellular products for Phase I/II clinical studies.

Additionally, they will work with Quality Assurance and the Director of Quality Control to ensure cGMP compliance of the QC FCL by writing and implementing Standard Operating Procedures (SOP) that clearly describe and delineate cGMP compliance as defined by FDA, FACT, ICH, EMA and MHRA regulatory requirements. 

 
 

Other duties include but are not limited to: Collaboration with the Director of Project Management (PM) on the development and implementation of timelines for assay development, transfer, validation, testing during cGMP manufacturing and real-time and accelerated stability studies. Generating documents that summarize release assay development and/or the technical transfer of methods to QC FCL. Write and maintain SOPs that pertain to the QC FCL. Write and coordinate the execution of method validation protocols. Train QC staff on QC FCL SOPs with subsequent assessment of personnel competency.

This individual will perform other related duties as assigned or directed to meet the goals and objectives of the CGL QC Flow Cytometry Laboratory, CGL Quality Control department, and St. Jude Children’s Research Hospital.

  • Oversees the daily operations of the QC FCL and aids in troubleshooting assays, projects, and equipment
  • Develops flow cytometry assays for in-process and release of cGMP and current Good Tissue Practice (cGTP) products
  • Generates reports of publication-quality that accurately and professionally represent assay transfer and development activities. These documents are subject to audits by the Food and Drug Administration (FDA)
  • Generates and executes assay validation protocols, cellular product stability protocols, and cellular product condition of use protocols that involve flow cytometry-based assays
  • Ability to work in an FDA-regulated environment
  • Trains personnel in procedures and document competency of QC FCL staff
  • Operates in a 21CFR Part 11 electronic environment
  • Performs critical review and approval of reports executed by QC personnel
  • Responsible for annual Performance Evaluations of QC FCL personnel
  • Maintains regular and predictable attendance
  • Master's Degree in biochemistry, chemistry, analytical chemistry or related field preferred.
  • Expertise in flow cytometry required
  • Ph.D. is preferred
  • Nine (9) years of relevant post-degree experience in flow cytometry required with a Master's degree.
  • Five (5) years of relevant post-degree experience in flow cytometry required with a Ph.D. degree

Preferred Expertise:

  • Applicant can demonstrate a history of experience and expertise operating BD Biosciences Flow Cytometry Instruments
  • Applicant can demonstrate a history of experience and expertise using BD FACSuite Software for Flow Cytometry Analysis
  • Applicant familiar with current Good Manufacturing Practices and working within a regulated environment.
St. Jude is an Equal Opportunity Employer

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COVID-19 vaccine:

St. Jude Children’s Research Hospital has mandated the COVID-19 vaccine for all employees, excluding those with an approved medical or religious accommodation, as a condition of employment.