Michael Huerta Email & Phone Number

United States

• Responsible and accountable for managing and providing leadership to manufacturing team during execution of cGMP manufacturing processing.• Establish and manage process transfer and manufacturing processing timelines for overlying projects. • Prepare, review and approve technical documents including Process Transfer Documents, Qualification protocols and Standard Operating Procedures / Work Instructions.• Prepare, review and approve project Batch Records and Solution Records• Participate dynamically in Facility Fit and tech transfer discussions• Develop process flow diagrams for facility fit and process design• Generate facility fit / operational Bill of Materials (BOM) for accelerating material ordering for project enrollment. • Collect, organize, and analyze process data from engineering and manufacturing runs for multiple manufacturing projects. • Facilitate closure of Process Deviations, CAPA and Change Controls. • Manage activities between Manufacturing and Process Development including Batch record/Solution record generation.• Provide assistance to Process Development group as a SME in cGMP processing and disposable manufacturing processing.

- Coordinate activities between Manufacturing, Tech Transfer and Process Development, including batch record generation, process development.- Develop Work Instructions for equipment such as 200L and 2000L Xcellerex Disposable Bioreactors, NOVA 400 BioProfile and Vi-Cell XR Cell Viability Analyzer- Provide assistance to Process Development group as a systems expert in cGMP process development. Methods have been developed to streamline process activities.- Develop Item Specifications for materials used in cGMP activities.

Cell CultureCoordinate activities for Manufacturing Associates to ensure production goals for shift/ group are met. Activities include the use of 2000-L, 650-L, 145-L, 100-L, 20-L, 15-L bioreactors and associated utilities. Ensure full compliance with both current Good Manufacturing Practices (cGMP) and with environmental, health and safety regulations by shift personnel.Author and review SOP's, Batch Records and/or Formulation records. Author deviation reports as required.Review timesheets for accuracy and approve Supervising and Training group personnel. Thus reducing the number of training gaps within the group.Coordinating activities between groups, as needed, to ensure success of processes and the companyTroubleshoot and maintain manufacturing equipment (including proper calibration and cleanings performed). Equipment includes Blood Gas Analyzer, YSI's (gluclose, lactate, glutamine and glutamate analyzers), Vi-Cell, Osmolarity meter, ph and conductivity meters and probes.Problem Solving skills include resolving, coordinate and document any compliance issues, equipment issues and/or personnel issues. Also Document and notify of any process deviations

Cell CultureTaken lead position on shift to help ensure that everyday operations are being completed as well as making preparations of upcoming events. Operated manufacturing in accordance with SOP's and batch/formulation records. Routinely troubleshooting bioreactors, process issues, etc.Certified trainer on key Standard Operating Procedures involving bioreactor steaming, cleaning and other key operations. Authored a number of Standard Operating Procedures and Formulation / Batch records for incoming projects.Tasks with running Small Scale project which included working closely with Process Development group to ensure process was ran in accordance with original process flow.

Operated in accordance with formulation/batch records and SOP's. Performed troubleshooting operations as needed.Performed fermentation operations in accordance with SOP's and formulation/ batch records.

Responsible for all aspects of establishing a new operation ready for production. Including equipment installation and ensuring all OSHA safety requirement where met.

Supervised subordinate watch standers in all facets of Engine room operationWork Center Supervisor - Coordinate and supervise the efforts of 15 personnel in the repair, overhaul and testing activities of more than 800 valves over the course of 6 months. Saving the US Navy in excess of $750,000 by performing the work within the work center rather than using other manufacturing resources.

Nuclear Energy Engineering Technology, Engineering

Education record