A Brief OverviewLocated in the Wolstein Lab
The Senior Cell Therapy Lab Specialist, without daily supervision, performs technical processing procedures related to autologous and allogeneic hematopoietic progenitor cells (HPC) and/or novel therapeutic cellular therapy products to treat patients within the Seidman Cancer Center Hematopoietic Malignancy and Cellular Therapy Program and Wesley Immunotherapy Center. Responsible for carrying out complex cell handling operations under sterile conditions and quality systems, troubleshoots, process development, improvement and workflows, writes and revises SOPs, and performs complex release testing. This role serves as a cell processing/manufacturing technical expert and mentor to the team.
What You Will Do- Without supervision, performs a variety of duties related to the processing of cellular therapy productsaccording to standard operating procedures. Processes stem cells from initial evaluation to finished productstatus in an accurate and timely manner using aseptic techniques. Prepares cellular products for infusion underappropriate regulatory and quality guidelines.
- Interfaces regularly with nurses, coordinators and physicians to prepare cell products for patient treatmentaccording to physician's orders. Assists clinical staff during the infusion of cellular therapy products. Preparesappropriate documentation for processing and infusion records.
- Achieves and maintains competency in common lab procedures including aseptic technique,cryopreservation/thawing, cell selection, centrifugation, and washing. Demonstrates proficiency with labequipment required for the processing of human products.
- Uses knowledge of stem cell transplant procedures, biology and lab analytics to interpret test results, including: automated and manual cell counts, viability, flow cytometry, infectious disease marker panels, and sterility testing. Performs patient dose calculations during processing to assess product yields.
- Labels cell products while maintaining chain of custody and identity in collaboration with the clinical and producttransport teams. Develops and optimizes lab procedures, data management, electronic record systems to meet departmental goals. Interfaces with Lab Medical Director and clinical team to meet clinical end points and Lab Director to optimize technical procedures.
- Works as part of a team to correlate data based on results, technical expertise, and other conditions affecting test results or process outcomes. Takes the lead to validate and develop new procedures and recommends improvements for operating procedures. Serves as a technical expert and provides training to other staff.
- Enters and maintains records of procedures and data, both manually and on electronic data capture systems.Reviews records for acceptability, accuracy, and completeness. Documents procedures according to GoodDocumentation Practice guidelines.
- Ensures equipment, reagents and supplies are properly utilized in accordance with manufacturer guidelines and/or standard operating procedures and performs reagent and instrument quality control at the appropriate intervals, interpreting and recording results. Ensures equipment is maintained according to regulatory guidelines and undergoes preventative maintenance and calibration on a regular schedule.
- Ensures critical reagents and supplies, material receipt, storage, and applicable manufacturer certificate of analysis conform with regulatory expectations prior to use. Utilizes reagents and supplies in accordance with manufacturer guidelines and/or standard operating procedures
- Ensures effective collection and shipment/receipt of cell products with appropriate documentation. Performs supply procurement and billing of executed procedures. Maintains a well-organized, stocked, and clean work area. Oversees inventory levels, to ensure adequate supplies.
- Serves as responsible party to report to the Cold Storage Governance Committee regarding cell product storage in liquid nitrogen. Ensures integrity of cell therapy products stored in liquid nitrogen are monitored 24/7 and are not compromised by thaw prior to infusion. Adheres to departmental guidelines, safety/regulatory requirements, and applicable regulatory and quality standards. Provides a safe environment for patients. Reports safety concerns, errors, and near misses related to cellular products for administration.
- Participates in the Lab Quality Management Program designed to ensure patient safety by process control and prevention of errors. Demonstrates and maintains knowledge of quality, safety, and compliance programs while maintainingrecords to meet standards/requirements of the hospital and licensing/accrediting agencies including, but notlimited to, FDA, FACT, CAP, and CLIA.
Additional Responsibilities - Performs other duties as assigned.
- Complies with all policies and standards.
- For specific duties and responsibilities, refer to documentation provided by the department during orientation.
- Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
Qualifications:Education- Bachelor's Degree in biological sciences, health sciences or related field (Required) and
- 7 years of experience in a clinical, analytical or biotech/Pharma, relevant research or industry laboratory or
- Master's Degree or PhD in biological sciences, health sciences or related field (Required) and
- 4 years of experience in a clinical, analytical or biotech/Pharma, relevant research or industry laboratory
Work Experience- less than 1 year experience in aseptic technique, quality and regulatory compliance (Required) and
- less than 1 year experience working in a highly regulated environment (Required)
Knowledge, Skills, & Abilities- Familiarity with laboratory equipment (Required proficiency)
- Knowledge of FDA, cGMP, and cGTP (Required proficiency)
- Exhibits excellent organizational, planning, and time management skills (Required proficiency)
- Good judgement, critical thinking skills, and problem solving abilities (Required proficiency)
- Excellent written, verbal, and interpersonal communication skills (Required proficiency)
- Extreme attention to detail (Required proficiency)
- Capable of working in a fast-paced and rapidly changing environment and technology R (Required proficiency)
- Working knowledge of Microsoft Word, Excel, and PowerPoint (Required proficiency)
Licenses and Certifications- Medical Lab Technician (MLT-ASCP) (Preferred Upon Hire) or
- Medical Technologist (MT-ASCP) (Preferred Upon Hire)
Physical Demands- Standing Frequently
- Walking Frequently
- Sitting Rarely
- Lifting Frequently 50 lbs
- Carrying Frequently 50 lbs
- Pushing Frequently 50 lbs
- Pulling Frequently 50 lbs
- Climbing Occasionally 50 lbs
- Balancing Occasionally
- Stooping Frequently
- Kneeling Frequently
- Crouching Frequently
- Crawling Occasionally
- Reaching Frequently
- Handling Frequently
- Grasping Frequently
- Feeling Constantly
- Talking Constantly
- Hearing Constantly
- Repetitive Motions Constantly
- Eye/Hand/Foot Coordination Constantly
Travel Requirements 
