Edwin Arias Email & Phone Number

Berkeley Ca

Facility Start-Up of cGMP manufacturing. Performed unit operations described in standard operating procedures and batch records. Recommend and execute projects and changes to bioprocess operations to reduce risk and increase efficiency. Performed Cell Banking, Cell Expansion, Mammalian Cell Culture, Harvest, Formulation, Downstream Purification, Column Packing, Viral Filtration, UF/DF, Fill, Weigh and Dispense. Complete required processing documentation including deviation reports, change control, product change over, etc. Participate in validation activities including IQ/OQ/PQ and process validation. Identify, creates, and revises GMP documentation as required including MBRs and SOP’s. Onboard and deactivate equipment.

Vacaville, Ca

Upstream and Operational Specialist performing cGMP bacterial fermentation and recovery activities; supervised manufacturing associates to prioritize daily tasks and deliverables; assisted management in the development of schedules and processes; addressed plans and maintenance of manufacturing methods along with processes and operations for new or existing products and technologies following cGMP guidelines. I collaborated with Facility Operations to ensure maintenance schedule of process equipment. Performed inventory transactions to ensure effective use of materials. I collaborated with senior management and quality assurance to implement production methods and techniques

700 Eubanks Dr. Vacaville Ca