Cellular Therapy Lab Specialist

Community Health Network, Inc.; Indianapolis (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Community Health Network in Indianapolis is seeking a Clinical Cellular Therapy Lab Specialist to perform specialized cell manipulation and testing for life-saving cellular products used in stem cell transplantation and cellular therapy.

You will follow strict SOPs, maintain sterile technique, and manage documentation across multiple FDA/QA standards while ensuring timely processing and high quality control. On-call rotations and day shifts are required.

Qualifications

• 2 year / Associate Degree Chemical or Biological Science, Clinical Laboratory Science, or Medical Technology (Required)
• 4 year / Bachelor’s Degree Chemical or Biological science, Clinical Laboratory Science, or Medical Technology (Preferred)
• In lieu of above, combination of experience and education considered.
• 1+ years: Experience in clinical cell processing (Preferred)
• 2+ years: Experience as a technician in a clinical laboratory setting (Required)
• Perform cell manipulation/evaluation following standard policies and procedures including cryopreservation, enrichment, thaw/wash and infusion.
• Maintain documentation in compliance with FDA GLP/GMP and other standards (FACT, CAP, CLIA).

Responsibilities

• Perform cell manipulation/evaluation procedures including cryopreservation, enrichment, thaw/wash and infusion.
• Document deviations and events and notify supervisor and QA personnel.
• Maintain aseptic/sterile technique during processing and adhere to gowning requirements.
• Calculate infusion cell doses, viabilities, dilutions, and concentrations accurately.
• Apply knowledge of donor evaluation, screening, testing, labeling and product release criteria.
• Coordinate supply inventory for procedures and projects.
• Participate in monitoring alarm reports and on-call rotation when excursions occur.
• Assist in validation of procedures and write SOPs.

Skills

Cell processing

Documentation

On-call readiness

Laboratory technique

Education

Associate degree in Chemical/Biological Science

Bachelor's degree in Chemical/Biological Science

Tools

Cryopreservation equipment

Job description

7979 Shadeland Ave
Indianapolis , IN 46250
United States

Shift

Day Job

Hours

0730-5 variable with on-call rotation for evenings and weekends for lab alarm response

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Where you fit in

The primary purpose of the Clinical Cellular Therapy Lab Specialist position is to participate in the performance of highly specialized and time sensitive

technical cell manipulation and testing procedures on irreplaceable, life-saving cellular products used for treatment of cancer

patients undergoing Stem Cell Transplantation and/or Cellular Therapy treatment.

LICENSE & CERTIFICATION REQUIREMENTS

Required Certifications/Licensures: (Certification as a professional Medical Laboratory Technologist (MT-ASCP or MT-AAB, or MTAMT) or an equivalent in area of specialty., Medical Lab Scientist (MLS) (ASCP))

Your exceptional qualifications and education

2 year / Associate Degree Chemical or Biological Science, Clinical Laboratory Science, or Medical Technology (Required)

4 year / Bachelor's Degree Chemical or Biological science, Clinical Laboratory Science, or Medical Technology (Preferred)

In lieu of the above education requirements, a combination of experience and education will be considered.

1+ years: Experience in clinical cell processing (Preferred)

2+ years: Experience as a technician in a clinical laboratory setting (Required)

Your exceptional skills

Perform cell manipulation/evaluation procedures following standard policies and procedures which include but are not limited to

stem cell and/or cellular product cryopreservation, cell enrichment, cell product thaw/wash and infusion.

Perform procedures and maintain accurate documentation in compliance with FDA’s Good Laboratory Practices, Good

Manufacturing Practices, 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 timely manner and assist in

investigation of cause and any required corrective actions.

Maintain aseptic and/or sterile technique during processing of products to ensure the integrity, viability, and sterility of cellular

products until final infusion to the patient. Must adhere to standard cleaning and gowning requirements for the facility.

Perform error-free calculations, including, but not limited to infusion cell doses, viabilities, dilutions and cell concentrations.

Demonstrate and maintain working and theoretical knowledge of current stem cell transplantation and cellular therapies including but not limited to procurement, processing, testing, storage, and transplantation. Knowledge of various cell sources such as bone marrow, peripheral blood stem cells, and cord blood is essential for understanding the rationale behind methods. Must maintain and apply knowledge regarding donor evaluation, screening and testing, labeling, and product acceptability and release criteria.

Required to adapt to variable nature of incoming cellular products/samples and participate in the receipt, storage, and transport of products for infusion.

Follow and adapt to procedures/policies implemented by external companies for commercial cell therapy products. Must adhere to all defined processing and documentation requirements for each product.

Utilize various computer systems and databases to enter, retrieve, and compile data, complete patient laboratory records, and prepare reports for review by laboratory directors, quality assurance, and physicians.

Coordinate and manage supply inventory required for clinical procedures as well as assigned projects and validations.

Participate in reviewing and evaluating monitoring alarm system reports and promptly notify appropriate manager or designee of excursions. Participate in on-call rotation in the event of an excursion that puts products at risk.

Participate in a flexible work schedule as needed to accommodate timely preparation of products with highest possible quality.

Perform quality control testing, equipment routine maintenance, basic and advanced troubleshooting. Participate in process and quality improvement projects.

Assist in validation of procedures and equipment. Participate in writing Standard Operating Procedures.

Perform routine environmental monitoring and equipment maintenance at designated time intervals.

Communicate with physicians/investigators, nurses, donor coordinators, internal and external testing laboratories and/or transplant facilities to ensure timely quality patient care.

Individuals may not perform all of these duties, or may perform additional, related duties not listed here.

Why Community?

At Community Health Network, we build teams that deliver exceptional care through empathy, communication and collaboration. We consider ALL an integral part of the exceptional patient experience. We PRIIDE ourselves on not having employees but Caregivers. Join our Community as we make a difference in your community.

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