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Medical University of South Carolina

Health sciences university in Charleston, SC

GMP Lab Technician 2-3

Full-Time
No salary listed
Mid
Bachelor's, Master's
Charleston, SC, USA
In Person
Biology & BiotechBioprocess & Biomanufacturing

About the job

Requirements
  • A four-year college degree with a major in medical technology or biological sciences.
  • At least 2 years of clinical cell therapy experience.
  • Basic hematology knowledge.
  • Motivation and initiative to learn new scientific theory and applications.
  • Mature judgment.
  • Ability to work independently with regular review of progress and results.
  • Ability to interpret data thoroughly.
  • Strong troubleshooting capabilities.
  • Scientific writing skills, including preparation of clear, concise standard operating procedures and technical reports.
  • Strong math skills.
  • Attention to detail.
  • Ability to differentiate between colors and pass a standardized color vision screen.
  • Ability to perform job functions while standing, sitting, and walking continuously; climb stairs infrequently; work indoors continuously, outside in temperature extremes infrequently, from elevated areas frequently, and in confined or cramped spaces frequently; kneel infrequently; bend at the waist continuously; twist at the waist frequently; squat frequently; perform pinching operations frequently; perform gross motor activities with fingers and hands continuously; grasp firmly and manipulate finely with fingers and hands continuously; reach overhead frequently and in all directions continuously; perform repetitive motions with hands, wrists, elbows, and shoulders continuously; fully use both legs continuously; use lower extremities for balance and coordination frequently; lift and carry 50 pounds unassisted infrequently; lift or lower objects weighing 50 pounds from or to the floor or 36 inches unassisted infrequently; lift 25 pounds from 36 inches to overhead infrequently; exert up to 50 pounds of force frequently; maintain corrected vision of 20/40 continuously; see and recognize objects at close hand or at a distance continuously; match or discriminate between colors continuously; determine distance and relationships between objects and depth perception continuously; maintain good peripheral vision continuously; maintain hearing acuity with correction continuously; perform gross motor functions with frequent fine motor movements continuously; deal effectively with stressful situations continuously; work rotating shifts and overtime as required frequently; work in a latex-safe environment continuously; and maintain tactile sensory functions continuously.
  • Must pass a respirator fit test and be physically qualified for respirator use initially and as required for selected positions.
  • Ability to maintain good olfactory sensory function for selected positions.
Responsibilities
  • Perform advanced cellular therapy manufacturing and laboratory operations supporting clinical, translational, and investigational cell therapy programs in a regulated good manufacturing practice environment.
  • Execute complex cellular processing workflows, including cell isolation, expansion, enrichment, selection, culture, cryopreservation, and quality control testing of human-derived cellular products.
  • Perform end-to-end manufacturing operations for advanced cellular therapies, including aseptic processing in classified cleanroom environments, accurate batch documentation, and product traceability and quality compliance throughout manufacturing.
  • Process apheresis-derived products, immune cell populations, stem cell products, and emerging cellular therapies in accordance with current good manufacturing practice, current good tissue practice, biosafety, and contamination-control requirements.
  • Collaborate with clinical, laboratory, research, and quality teams to develop, optimize, validate, and implement novel cellular therapy manufacturing processes, including CAR-T, mesenchymal stem cell, dendritic cell, and other advanced therapeutic platforms.
  • Contribute to process improvement initiatives, equipment and procedure qualification activities, standard operating procedure development, and standardized workflow implementation for translating cellular therapies from research into clinical application.
  • Perform complex immunological, hematological, and cellular analyses to support product characterization, assay validation, and laboratory quality programs.
  • Use flow cytometry, ELISA-based assays, functional immune testing, and cellular analysis to evaluate product performance, investigate technical challenges, and generate data supporting manufacturing decisions and continuous improvement.
Desired Qualifications
  • A master's degree with a major in medical sciences or a related field.
  • Experience working within an academic good manufacturing practice laboratory, including familiarity with FDA and FACT accreditation requirements.
  • Flow cytometry expertise.
  • Immunotherapy experience.
  • Cell selection operation experience, such as manual cell selection or CliniMACs.
  • Moderate laboratory information system knowledge, such as Bluecord or Stemsoft.
  • A strong understanding of current good manufacturing practice and current good tissue practice standards.

About the company

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Medical University of South Carolina

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Medical University of South Carolina is a public academic health sciences university in Charleston, South Carolina. It offers bachelor's, master's, doctoral, and professional degrees through six colleges in dental medicine, graduate studies, health professions, medicine, nursing, and pharmacy.

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