Processing Technician, Cellular Therapy

** Responsibilities*
* This position is responsible for performing processing, cryopreservation, and testing of the hematopoietic progenitor cell products and parathyroid tissue for hospital clients.

+ Facilitate receipt of cellular therapy products by reviewing processing and collection order forms, forwarding forms to clinical apheresis team as applicable, communicating by email and phone with client transplant centers to schedule transport of products to the lab and to obtain and provide required documents,

+ Process HPC, Apheresis, HPC, marrow and parathyroid tissue by following established procedures for aseptic technique, including but not limited to, cell and volume reduction, cryopreservation of viable products

+ Perform calculations, including, but not limited to cell concentrations in products, dilutions required for cryopreservation and dispensing requested therapeutic doses of cells, volumes of cells needed for infusion, and viabilities.

+ Receives and accessions cellular therapy products

+ Prepares samples for testing, enters sample 's into electronic system, inspects and packs samples for shipment to testing laboratories.

+ Prepares units for shipment to the transplant center. Prepare labels, reports, and shipping containers for shipments. Retrieves products from storage and confirms identity of the products. Packs products in appropriately prepared shipping containers. Release the products to courier for shipment to transplant center.

+ Compliance with FDA, NYSDOH regulations, AABB and FACT standards, and other applicable requirements, regulations and standards.

+ Perform daily weekly, monthly, and annual QC on laboratory equipment and freezers as described in the laboratory SOPs.

+ Assist in maintaining accurate documentation in compliance with FDA's Good Laboratory Practices, Good Manufacturing Practices, and Good Tissue practices regulations as well as standards set by other accreditation agencies including but not limited to FACT, FACT/Netcord, CAP, CLIA. Document deviations and events; notify supervisor, technical and quality management personnel in a timely manner.

+ Ensure that patient charts contain all necessary documents and lab reports as described in laboratory SOPs. Accurately maintain and enter data in the current laboratory computer system (i.e., excel spreadsheets and Stem Soft software). Obtain patient test results from other laboratories.

+ Maintains accurate inventory of laboratory supplies.

** Qualifications*
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* Education:

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* + Bachelor Degree in Medical Technology, Biology, Chemistry or Physical Science.

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* Experience:

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* + 0 to 2 years' experience working in Cellular Therapy, Clinical or Research laboratory.

** Knowledge:*
* + Good Manufacturing Practice guidelines for cell therapy clinical trials.

+ Knowledge of processing, purging, cryopreserving, thawing, and preparing cellular therapy products for infusion/transplantation.

+ Aseptic/sterile technique.

+ FDA and NYSDOH regulations and AABB and FACT standards.

+ Working knowledge of computerized systems.

+ Working knowledge of quality control procedures.

+ A variety of software applications (Microsoft Office Suite).

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* Skills:

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* + Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.

+ Skill in pipetting.

+ Attention to detail in all work processes.

+ Demonstrated critical thinking and troubleshooting skills.

+ Mathematical skills necessary to calculate cell concentrations.

** Abilities:*
* + Ability to learn scientific processes in an expedient manner.

+ Ability to follow protocols to maintain quality systems.

+ Ability to communicate clearly and with authority, both in writing and verbally, to others in one-on-one or small group settings.

+ Ability to interact with individuals at all levels of the organization and customers in a helpful, courteous and friendly manner while demonstrating sensitivity to and respect for diverse populations.

+ Ability to plan and organize job tasks or resources in an efficient manner.

+ Ability to be responsive and available to management in order to address issues and concerns as they arise.

+ Ability to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.

+ Ability to follow HIPPA regulations for donor/sample security.

Any combination of education, training, and experience equivalent to the requirements above that has supplied the necessary knowledge, skills, and experience to…