Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000
Cell:
resumesample@example.com
Summary
Experienced GMP Laboratory Supervisor with a demonstrated history of working in the hospital & health care industry on various clinical trials dealing in Immunotherapy. Skilled in GMP production for cellular therapy, Cell Culture and Clinical Research.
Skills
Processes and procedures
Knowledgeable in Cell Therapy
Experience
Supervisor, 07/2014 to 01/2020 Downer Edi Limited – Springvale, ME,
Serves as Supervisor and mentor to both Senior and Clinical Cell Therapy Specialist by:.
Cell Manipulation and Processing.
Train all Clinical Cell Therapy Specialist (CCTS) to perform cell manipulation/evaluation procedures following standard policies and procedures which include but not limited to cellular product cryopreservation, cell culture, cell product thaw/infusion, etc.
Complete responsibility and awareness is required while performing procedures which may take from few hours to over 36 hours before completion.
Certain procedures may require several days of processing over an extended time such as 2-6 weeks.
To ensure ownership and accountability of critical steps, procedure/product is assigned to one (maximum of two for certain procedures) CCTS technologist who is responsible for the entire process on scheduled days required per protocol until product is infused into the patient.
Train all Clinical Cell Therapy Specialist (CCTS) to perform procedures and maintain accurate documentation in compliance with FDA's Good Laboratory Practices, Good Manufacturing/Good Tissue practice regulations as well as standards set by other accreditation agencies.
Training on how to 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.
Supervise the CCTS to validate proper aseptic technique during processing of products to ensure the integrity, viability and sterility of cellular products until final infusion to the patient.
Making sure the CCTS adhere to special cleaning and gowning requirements for both the SCRB & GMP facility.
Make sure the CCTS perform error free calculations when dealing with patient products in GMP and SCRB.
Checking folders for accuracy in reporting and to finalize patient folders before Quality Assurance audits.
Serve as a mentor in increasing efficiency in advanced cell processing, new technologies & laboratory techniques and adapting the procedures/policies towards implementation.
Product monitoring, receiving, storage and retrieval.
Help the CCTS adjust to a flexible work schedule dependent on patient conditions and product/sample availability is required.
Cell products are received at any given time with very short advance notice and late night or weekend work may be required.
The Clinical Supervisor will make sure all procedures/products have coverage when needed & that the proper amount of support will be available.
The Clinical Supervisor will work with the Research Supervisor on all validation & time sensitive procedures so the CCTS schedule is worked out in a timely manner and that the preparation of products will be processed with highest possible quality.
Utilize various computer systems and databases to enter, retrieve and compile data, complete patient laboratory records and prepare reports for review by the TIL Director and Quality Assurance personnel.
Oversee the coordination and management of supply inventory required for clinical procedures as well as assigned projects and validations.
Transfer Technology and Quality control.
Train CCTS to perform quality control testing, equipment routine maintenance, basic and advanced troubleshooting.
TIL patient products are unique; if equipment malfunctions during processing, technologist must be able to rescue product.
The Clinical Supervisor will also participate in process and quality improvement projects.
The Clinical Supervisor will assist the Research Supervisor in the transfer of novel technologies from translational research to the clinical setting.
Validations of procedures and equipment, training of technologists and writing Standard Operating procedures.
The Clinical Supervisor will also communicate with physicians/investigators and nurses to ensure timely quality patient care.
Proper communication between the clinical staff is key.
The supervisor will work with the physicians/nurses and also the SCTCT clinical staff to ensure all patient care is priority and carried out in a timely manner.
Performed evaluations and reviews for 7 employees.
Monitored employee performance and conducted retraining to correct problems and optimize productivity.
Performed evaluations and reviews for 7 employees.
Interviewed applicants, recommended individuals for hiring and evaluated staff performance.
Conducted training needs assessments and provided ongoing training for staff.
Supervised successful team of 7 specialists by conveying project information consistently, quickly resolving issues and delivering constructive feedback.
Senior Clinical Cell Therapy Specialist, 09/2011 to 07/2014 MD Anderson Cancer Center – City, STATE,
Serves as a mentor and resource to cell therapy specialists by:.
Training cell therapy specialists in multiple research responsibilities which include solid tumor processing, daily media changes and cell culture responsibilities, cryopreservation of T-cells for the Rapid Expansion Protocol (REP) in the GMP facilities and satellite vials to be used for various basic science testing, i.e.
ELISA's.
Teaching and performing quality control testing, routine equipment maintenance along with basic and advanced troubleshooting of equipment used in specialized procedures.
Scheduling patient surgeries and infusions with clinical personnel (physicians/surgeons, research & clinical nurses and ICU staff) to ensure proper and timely treatment options for optimal patient care.
Proactively and independently performing highly specialized, time sensitive cell manipulation and testing on irreplaceable cellular products.
Following and adapting to procedures/policies implemented by study sponsors and adhering to all defined processing and documentation requirements.
Validating studies that either improve patient outcome, i.e.
TNF-a and Anti-41BB studies, or provide cost effective/reductive means to optimize patient care including:.
IL-2 dosing - Formalized & performed a series of mini Rapid Expansion Protocol (REP) procedures using varying degrees of IL-2 dosing to ensure the highest quality of care in patient cell growth while minimizing the amount of cytokine needed to reduce overall expenses for the trial.
Baxter vs.
AFC cell culture bag - Performing cells growth procedures in different types of cell culture bags to properly test growth, expansion and functionality of cells in relationship to current cellular benchmarks while reducing materials needed and expenses.
Coordinating and managing supply inventory to guarantee sufficient supplies are on hand to treat multiple patients simultaneously and maximizing space used while reducing supplies lost to expiration.
Taking a lead role in the completion of assigned projects, the transferring of novel technologies, completion of validated procedures/equipment and writing/revising standard operating procedures.
Performing cell manipulation procedures following standard policies and procedures that include stem cell and/or cellular product cryopreservation, cell culture, cell product thaw/wash and infusion.
Performing procedures and maintaining accurate documentation in compliance with FDA, GLP, GMP/GTP regulations as well as standards set by other accreditation agencies including but not limited to FACT, CAP and CLIA.
Demonstrating and maintaining a working and theoretical knowledge of current stem cell transplantation and cellular therapies including procurement, processing, testing, storage and transplantation.
Adjusting to a flexible work schedule, as laboratory processing is dependent on patient/donor conditions, product/sample availability, age of collected cells as well as procedural modifications required to adapt to the variable nature of incoming cellular products/samples.
Utilizing 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 personnel and physicians.
Clinical Cell Therapy Specialist, 05/2006 to 09/2011 MD Anderson Cancer Center – City, STATE,
The primary purpose of the Clinical Cell Therapy Specialist is to perform complex, highly specialized and time sensitive technical cell manipulation and testing procedures on irreplaceable cellular products in a Good Manufacturing Practice (GMP) facility.
The Clinical Cell Therapy Specialist is also responsible for the following tasks:.
Performs aseptic handling of cell manipulation procedures such as cell enrichment, cell evaluation and sorting, cell culture, cellular product cryopreservation, cell product thaw/wash and infusions.
Performs calculations on infusion cell doses, viabilities, dilutions and cell concentrations.
Performs procedures and maintains accurate documentation in compliance with regulations.
Follow procedures and policies implemented by Principal Investigator and adheres to all defined process and documentation requirements.
Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.
Performs quality control testing, routine equipment maintenance and troubleshooting.
Performs quality control and quality assurance of all tests/assays.
Performs and handles human peripheral blood for processing and tracking.
Coordinates and manages supply inventory.
Education and Training
Bachelor of Science: Clinical Laboratory Science, Expected in 08/2005 Texas State University - San Marcos, TX, GPA:
Bachelor of Science: Biology & Psychology, Expected in 05/2001 Southern Arkansas University - Magnolia, AR, GPA:
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