Nationwide Children's Hospital

Cell-Based Therapy Specialist II

Posted Date 3 weeks ago(3/22/2021 10:50 AM)
Requisition ID
2020-26446
Category
Research

Overview

Cell-Based Therapy Specialist II- Cell-Based Therapy Core

Full-Time; Benefit Eligible

 

The primary responsibility of a Cell-Based Therapy Specialist II in the Cell-Based Therapy (CBT) Core is the preparation and characterization of cellular products used for therapeutic applications. A Specialist II must be proficient in all techniques commonly used, and these duties must be performed in compliance with all applicable regulations, standards, and guidelines to ensure the highest possible quality cell product. Specialist II will lead projects and training. Additionally, the Specialist II will translate and optimize manufacturing procedures.

Responsibilities

 

What Will You Be Doing?

  • Follows aseptic techniques, current Good Tissue Practices (cGTPs) and current Good Manufacturing Practices (cGMPS), and all applicable Cell Therapy Laboratory standard operating procedures 
  • Prepares cell processing reagents 
  • Performs all standard cell processing procedures that are considered minimal manipulation, including, but not limited to, processing and cryopreservation of hematopoietic progenitor cells and immune effector cells, cell selection, thawing cells at bedside for infusion
  • Performs QC testing on cell products processed in the CBT Core, including, but not limited to, nucleated cell and platelet count, hematocrit, viability assay, colony forming unit assay, and other cell proliferation and functional assays, sterility assays (mycoplasma, endotoxin, gram stains), flow cytometry, and PCR 
  • Operates equipment for cell processing and testing according to standard operating procedures 
  • Performs calculations to determine patient cell dose information on which clinical decisions are made 
  • Performs cGMP-level cell processing procedures that are considered manipulation, alter the relevant biological characteristics of the cells, and produce products that are regulated as drugs or devices. This includes, but is not limited to, cell expansion, differentiation, activation, combination with a drug or device, transduction for gene therapy, or complex isolation procedures
  • Performs proper notification and documentation of cell products not meeting required release criteria and any circumstance detected in the CBT Core that differs from approved or standard practice
  • Performs necessary equipment checks, performance testing, preventive maintenance, and quality control 
  • Ensures that equipment consistently meets performance standards, resolves minor equipment problems and requests appropriate service for major problems 
  • Controls receipt of critical reagents and supplies, including quarantine and release processes, and performs QC testing on reagents and supplies as appropriate
  • Participates in proficiency testing programs as required 
  • Assists with other quality assurance projects as assigned Leadership 
  • Assists CBT Scientific Director in training of new employees on all laboratory procedures. 
  • Assists CBT Scientific Director in training of new procedures, and proficiency testing for established procedures, for current employees.
  • Conducts training sessions for visiting students, residents, or fellows rotating through the laboratory. 
  • Participates and/ or oversees the validation of new procedures and/ or equipment, including writing validation protocols, performing validation tests, documenting results, performing statistical analyses, and establishing control systems, when possible. Compiles data and makes recommendations based on results. 
  • Assists in writing and revising standard operating procedures. Performs validation of new or revised SOPs. 
  • Acts as CT Manager in the manager’s absence. Technical Expertise 
  • Demonstrates mastery of all technical procedures and serves as a technical resource for less senior staff
  • Develops/ translates pre-clinical research into clinical scale cell processing procedures Performs other related responsibilities as required by the CT Manager and/ or Director.

Qualifications

What Are We Looking For?

 

  • Master’s degree preferred and/or 3-5 years’ experience in cell manufacturing. 
  • Advanced knowledge in multiple skills: aseptic technique and cell culture, working in a clean-room environment, flow cytometry, transfection and transduction methods, PCR including qPCR, microbiological testing, cell processing and isolation techniques, and use of cell manufacturing equipment (Prodigy, Xuri, LOVO, etc.). 
  • Must adhere to a day-shift/flexible schedule. Due to the unpredictable nature of our patient’s needs, and the rapid pace at which products must be manufactured, this job may require effort afterhours (nights and weekends). Scheduling and compensated overtime will be assigned as needed, and at the discretion of management. Physical/Visual/Mental Requirements
  • Must be prepared to work with human blood, blood products, and tissues. 
  • Able to move oneself from one area to another throughout the Hospital complex
  • Able to communicate effectively with all levels of Hospital staff, patients, and visitors
  • Able to manipulate objects in both hands at the same time, manual dexterity for typing, grasping, pipetting, and operating equipment 
  • Able to maneuver large liquid nitrogen supply tanks throughout the laboratory 
  • Able to stoop, crouch, and climb a ladder to reach supplies
  • Clear vision in all dimensions required
  • Color vision required for cell counting and viability assays 
  • Good verbal, writing, and teaching skills 
  • Good critical thinking and problem-solving skills
  • Able to easily learn new processes, techniques, and disciplines
  • Good basic computer skills with working knowledge of word processing and spreadsheet programs Work Environment
  • The following risks of exposure are associated with the CBT Core: extreme cold and asphyxiation from liquid nitrogen, hazardous chemicals, potentially infectious agents contained in patient cell products, and infected patients. 
  • CBT Core employees are deemed essential and therefore are expected to report for work as scheduled during severe weather.

 

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

 

EOE M/F/Disability/Vet

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