Clinical Cell Engineer Specialist II - Stem Cell Transplantation Research
Houston, TX, United States
SUMMARY
The primary purpose of this position is to independently perform complex, 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.
The ideal candidate will have GLP and/or GMP experience.
KEY FUNCTIONS
Cell Manipulation and Processing
Perform cell manipulation/evaluation procedures following standard policies and procedures which include but not limited to stem cell and/or cellular product cryopreservation, cell enrichment and/or purging, cell evaluation and sorting, cell culture, cell product thaw/wash and infusion. 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) SCTCT technologist who is responsible for the entire process on scheduled days required per protocol until product is infused into the patient.
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 technique during processing of products to ensure to ensure the integrity, viability and sterility of cellular products until final infusion to the patient. Must adhere to special cleaning and gowning requirements for the facility and may be required to work in clean room environment requiring specialized gowning such as masks/goggles, sterile jumpsuits, hair and shoe covers.
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.
Product monitoring, receiving, storage and retrieval
Adjust to a flexible schedule 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 variable nature of incoming cellular products/samples. Cell products are received from facilities around the world and therefore working late nights, weekends and holidays with very short advance notice may be required. Adaptability and flexibility to procedural and schedule changes to ensure timely preparation of products with highest possible quality.
Follow and adapt to procedures/policies implemented by internal or external study sponsors on various clinical trials that may differ from standard operating procedures of MDACC Cell Therapy Laboratory. Must adhere to all defined processing and documentation requirements for the clinical trial.
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.
Transfer Technology and Quality control
Perform quality control testing, equipment routine maintenance, basic and advanced troubleshooting. Stem cell products are unique, if equipment malfunctions during processing, technologist must be able to rescue product. Participate in process and quality improvement projects.
Assist in transfer of novel technologies from other institutions and companies, validation of procedures and equipment, training of technologists and writing Standard Operating procedures.
Communicate with physicians/investigators, nurses, donor coordinators, internal and external testing laboratories and/or transplant facilities to ensure timely quality patient care.
Perform additional related duties as assigned.
CORE VALUES
Caring Behaviors
· Courtesy: Is respectful and courteous to each other at all times
· Friendliness/Teamwork: Promotes and rewards teamwork and inclusiveness; Is sensitive to the concerns of our patients and our co-workers
Integrity Behaviors
· Reliability: Communicates frequently, honestly and openly
· Accountability: Holds self and others accountable for practicing our values
· Safety: Notices a safety concern and brings it to someone's attention; Models safe behaviors (wears badge, washes hands, keeps work area clean and orderly)
Discovery Behaviors
· Responsiveness: By his/her actions, creates an environment of trust; Encourages learning, creativity and new ideas
· Personal Leadership/Self-Initiative: Helps others to identify and solve problems; Seeks personal growth and enables others to do so
EDUCATION
Required: Bachelor's degree in a relevant scientific field.
EXPERIENCE
Required: Three years of experience in clinical cell processing.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
Requisition ID: 166587
Employment Status: Full-Time
Employee Status: Regular
Work Week: Day/Evening
Minimum Salary: US Dollar (USD) 64,875
Midpoint Salary: US Dollar (USD) 82,500
Maximum Salary : US Dollar (USD) 97,400
FLSA: non-exempt and eligible for overtime pay
Fund Type: Soft
Work Location: Onsite
Pivotal Position: Yes
Referral Bonus Available?: No
Relocation Assistance Available?: Yes
Science Jobs: No
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