Cellular Therapy Laboratory Specialist

HNL Lab Medicine•Allentown, PA

13d•Onsite

About The Position

Performs aseptic processing of cellular therapy products to generate high quality cellular therapy products that adheres to all cGTP/cGMP regulatory requirements. Under the direction of the Cellular Therapy Lab Manager, the Specialist is responsible for performing cell manipulations on cellular therapy products for treatment of cancer patients undergoing stem cell transplantation and/or cellular therapy treatment.

Requirements

Bachelor’s degree required in medical technology or related science field from an accredited institution.
Ability to read, analyze, and interpret common scientific and technical journals.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to perform defined calculations and work with mathematical concepts such as fractions, percentages, ratios, and proportions.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Word processing, Spreadsheets, E-mail, Laboratory Information Systems, and ability to use various computer systems and or databases.

Nice To Haves

Certification by a recognized certifying agency for clinical laboratory professionals preferred (ASCP, ASMT, NCA, etc).

Responsibilities

Performs aseptic processing of cellular therapy products following standard policies and procedures including but not limited to, cryopreservation, thawing, cell depletions and enrichments, and product infusions.
Stores, transports, and documents all processing for products in the Cellular Therapy Lab.
Accurately performs calculations and reports cell doses and other related metrics to clinical staff.
Effectively communicates with physicians, nurses, and other internal and external stakeholders.
Performs and documents quality control, maintenance, and routine cleaning of Cellular Therapy Processing equipment following Standard Operation Procedure.
Follows Standard Operating Procedures and maintain accurate/legible documentation according to but not limited to cGTP/cGMP, FACT regulations.
Adheres and follows all safety policies and procedures.
Reports and assists with completing non-conformance, investigation and deviation reports with the Cellular Therapy Lab Manager and Quality Manager in a timely manner.
Recognizes and corrects instrument malfunctions within the scope of the operators’ manual and records troubleshooting activities under the direction of the Cellular Therapy Lab Manager.
Adapts to a flexible work schedule to receive cell products that come late in the day.
Maintains aseptic technique and training competencies.
Adheres to PPE requirements for the Cellular Therapy Lab and other internal areas.