Cell Component Specialist University of Maryland Medical Center

Responsibilities:          

Under general supervision operate Marlene & Stewart Greenebaum Cancer Center (MSGCC) Cell Therapy Lab or Fannie Angelos Cellular Therapy (FACT) Lab to include manufacturing processing manipulation and cryopreservation of HPC and related cellular products distribution and shipment of HPC and related products to University of Maryland Medical Center (UMMC) clinical areas and outside facilities. Ensure activities are performed in accordance with accepted standards and practices as well as regulations stipulated by Foundation for Accreditation of Cellular Therapy US Food and Drug Administration and other agencies as required by activity.  Provide support of sponsor-initiated clinical research trials that require management of trial-related documents and investigational products (IP) including formulation of IP for administration to patient.

Serve as principal technical resource to clinical staff in specialized area of cell therapy including cryopreservation of HPC and related products.  Responsible under direction of lab leadership for ordering and acquisition of supplies and equipment personnel training and competencies for small lab unit.

Specific responsibilities include:

• Perform document and teach cell manufacturing collection processing cryopreservation and thawing and infusion of HPC and cellular products in accordance with governing standards and departmental policies and procedures.
• Comply with established departmental standards practices and procedures follow strict principles of asepsis use standard techniques to manufacture cryopreserve and store human cells and cell products.
• Maintain and troubleshoot complex and equipment including cell sorting machines and other calibrated lab equip unique to cell therapy.
• Keep up with latest trends in cell therapy lab science and recommend add or modification of lab equipment as necessary. Participate in instrument and equipment qualification validation maintenance calibration and documentation of processes.
• Implement quality control program.  Test and evaluate equipment operation environmental monitoring and various control levels within specimens.  Document test results using good documentation standards.
• Draft standard operating policies procedures and protocols re lab operations and maintenance. Recommend changes in lab procedures to assure efficient and effective operation of lab and to reflect current Fact FDA State and Joint Commission Standards and other regulating or accrediting agencies.
• Ensure compliance with requirements of accreditation and regulatory agencies by participating in periodic inspections internal/external audits.  Participate in Quality Management System by reporting and investigating occurrences and planned deviations and implementing corrective actions/process improvements under direction of quality.
• Assist in evaluation of process performance and recommend initiate and effect measures to improve services and quality of cell therapy.  Assist in design and development of new services.
• Participate in research development and implementation of processes or improved lab procedures and techniques.  Make recommendations to improve/augment efficiency and effectiveness of cell therapy services.
• Prepare complete and maintain records and reports to document technical quality control budgetary personnel and supply activities of unit.
• Perform and maintain data collection including data from cell sorting machines used to evaluate quality of individual cellular products and look for trends to improve cell manufacturing. computer data storage data analysis and statistics.
• Maintain complete department records for collection and/or disposition of all blood and compounds collected and processed by Cell Therapy Lab.
• Collaborate with medical and nursing staff to prepare cell products and dispense cell products to patients at best time for patient care.
• Participate in lab correlative studies for clinical trials related to cellular therapy as per IRB approved clinical trials.
• Manufacture clinical trials related cellular therapy in ISO - Class 5 and 7 GMP facility and dispense products to patient care.

Qualifications :

Requirements

• Bachelors degree in Medical Laboratory Technology Biology Biotechnology Microbiology Chemistry Biomedical Engineering or related.
• Six (6) months of experience performing cell culture.

Additional Information :

All your information will be kept confidential according to EEO guidelines.

• Pay Range: $70000 - $85000 per year
• Benefits: Health vision dental and life insurance 403(b) retirement plan paid time off educational assistance employee assistance program and employee discounts.

Remote Work :

No

Employment Type :

Full-time