Description

The processing technologist will be responsible to perform and assist in coordination of all operational aspects of cord blood and cell therapeutic manufacturing process. He/she will also perform all laboratory activities, to include high complexity testing and training, according to approved standard operating procedures and industry regulations. Must work well with others.

•         Perform required tasks in accordance with approved policy, process and procedures.
•         Responsible for performing sample processing, cryopreservation, and quality control procedures upon completion of training.
•         Operate complex laboratory equipment for the sample processing, cryopreservation, and quality control procedures, including flow           cytometer, hematoanalyzer, and controlled rate freezer.
•         Perform tissue cultures.
•         Process cord blood and related process and procedures
•         Process adipose and birth tissue into clinical grade research products
•         Assist in the preparation of daily activity reports related to operations as required.
•         Recognize unacceptable results and unexpected events encountered in all phases of cell therapy processing.
•         Perform process and procedure validation as assigned.
•         Perform general lab cleaning and instrument maintenance as assigned.
•         Perform laboratory testing through performance of high complexity, routine, and special laboratory procedures. 
•         Perform cord blood accessioning, testing, processing, and maintain quality control records within compliance. 
•         Monitor incoming samples for testing and ensure that integrity of the sample is maintained (i.e. temperature, timing, etc). 
•         Responsible for the review of all test results. 
•         Perform processing, analytical testing, packaging and labeling of cord blood product, associated cord blood sample(s), adipose tissue          product(s) and other adult stem cell associated sample(s), according to procedures of NMDP, AABB, FDA and cGTP and cGMP                      standards. 
•         Ensure that all aspects from collection, processing, testing, and distribution are integrated. 
•         Utilize the data management system to include Excel, Word and LIMS system 
•         Maintain adequate level of disposable supplies through request for purchase of additional supplies. 
•         Assist in the preparation of daily activity reports related to processing, resolution of discrepancies, and retention of products not                  qualified for release. 
•         Recognize unusual results and difficulties encountered in all phases of laboratory performance to include purchased goods,                          environmental, mechanical and product related. 
•         Assist and develop testing procedures according to the NMDP, AABB, FDA and cGMP standards. 
•         Assist with validation of all procedures performed thus providing for the safety and efficacy of product to include preventative                    maintenance
•         Attend meetings, seminars, and other workshops as required
•         Maintain a close working relationship with the Laboratory Director and CEO keeping them informed on issues pertaining to                          laboratory  functions.
•         May perform other task as assigned 

Requirements

Minimal Education Requirements:  B.A. or B.S. in biology, medical technology or related scientific discipline

•         General laboratory experience
•         Excellent understanding of aseptic technique
•         Knowledge of FDA cGTP and cGMP laboratory practices
•         Cell culture experience
•         Knowledge of flow cytometry         
•         Complete initial and annual training as required.
•         Maintain continuing education requirements as expected.
•         Maintain a close working relationship with management.
•         Ability to perform tasks repetitively while maintaining attention to detail.
•         Ability to work in a clean room environment at least 75% of every 8 hour period worked
•         Able to work weekends; holidays.
•         Able to adapt quickly to an ever changing environment.
•         All other duties as assigned.
•         Must have a positive attitude.
•         Must be a self-starter and not wait to be told what to do.
•         Must have excellent critical thinking skills
•         Must have excellent multi-tasking skills
•         Must have a tolerance for ambiguity