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Process Development Associate

Scope of Position:
Up-stream process development for large-scale lentiviral vector production using 293 stable cell line for phase III clinical trial and commercial production. In detail, the work requires cell culture, molecular cloning skills and weekend working schedule. Responsible for laboratory maintenance, recording notebook, preparing solutions and media and ordering supplies. Works with bio-hazardous materials.
 
Major Responsibilities:

·         Extensive cell culture experiences including aseptic cell culture techniques, maintaining and passaging cell culture and cryopreservation.

·         Monitoring and analysis cell culture growth by Bioprofile and medium analysis.

·         Operating WAVE bioreactor from 1L to 50L scale including optimizing feed/harvest strategy and rocking condition.    

·         Titration of vector production by p24 Elisa assay and Taqman PCR.

·         Characterization of vector product during the entire production period using SDS-PAGE, western blot, HPLC, potency assay and RCL assay.

·         Technology transferring of the developed process to the GMP production group and supporting GMP production.

·         Operates requisite laboratory equipment and instruments such as centrifuges, incubators, light microscope, balance, and pH meter and water baths. 

·         Uses universal safety precautions to protect self and co-workers from biohazardous materials, including blood-borne pathogens.

·         Complies with biohazard safety standards through proper handling of potentially hazardous chemical and biological agents in the workplace.

·         Prepares solutions, reagents, and stains following standard laboratory formulas and procedures.

·         Uses sterile techniques to avoid contamination, utilizes laminar flow hood.

·         Prepares, cleans, sterilizes, and maintains laboratory equipment, glassware, and instruments used in the manufacturing process.

·         Monitors inventory levels, orders materials and supplies in accordance with established policies and procedures.

·         Writes and reviews Standard Operating Procedures/Manufacturing Procedures. Complies with GLP and GMP regulations.