Ariana Pedraza Email & Phone Number

California, United States

United States

• Under minimal supervision performs various manufacturing task including, filtration, formulation and in-process. Preparation of formulation components and product development projects in accordance with SOP’s, MBR’s and cGMP regulations. • Operates with equipment such as TFF systems, Filter testing, Homogenizer, SIP, autoclave, dehydrogenation oven, mixers, LNP systems, BSC during BSL2+ operations and CIP systems.• Initiates revisions/authoring to Master Production Batch Records, Forms, Job Aids and SOPs.• Participated in CC’s, OOTI’s, Asset inductions, IQ/OQ/PQ, URS and RM specifications.• Collaborates with other technical personnel with troubleshooting and engineering activities.• Works closely with Production Planner to manage QAD work orders to ensure production materials are obtained according to the manufacturing schedule.• Maintains and qualifies aseptic bulk production operations in GMP production facilities containing over 27,000 square ft. of Grade A,B,C and D clean room areas

• Plans and performs various routine upstream GMP manufacturing tasks with high focus on attention to detail.• Under minimal guidance interfaces with equipment software systems in regards to fermentor, and bioprocessing systems. • Requires minimal oversight to execute 100/120/1000L Fermentations, Harvest, Lysis, Crude IBs, Media preparation, Filtrations, CIP, SIP and TFF operations for Plasmids and Proteins. • Responsible for routine maintenance of upstream production equipment. • Collects process data for metrics/data trending. • Trained junior team members.

11040 Roselle St, San Diego, Ca 92121

• Perform sanitization duties in the cleanroom while being aseptically gowned• Properly formulate sterile/non-sterile disinfectant cleaning solutions in DP/DS and ISO 5-8.• Record and complete documentation as needed, including forms and logbooks in compliance with cGMP guidelines.