Michael Goetz Email & Phone Number

Tampa/St. Petersburg, Florida Area

Design and execute research and development for numerous critical parameters for specified process in pilot scale. Generate and review protocols for cleaning and sampling studies, master batch records, Standard Operating Procedures (SOPs), preventative maintenance, Installation Qualification and Operation Qualification (IQOQ). Perform batch record reviews, closure of batches in Great Plains. Train Bio-Processing Technicians on equipment use, cleanings, and SOP compliance. Perform cleaning of equipment, process rooms, and facility. Perform equipment assembly/set-up and document entry activities. Perform and document tasks as outlined in applicable SOPs and Master Batch Records. Support process and facility operations by complying with company and FDA cGMP requirements.

Tampa/St. Petersburg, Florida Area

Support pilot process development related to Sacrosidase development at Xcelience. Design and execute process specific experiments as instructed by Company. Write and implement equipment SOPs. Assist Company and contract manufacturer with Sacrosidase related equipment and processes. Provide training to Company employees as requested by Company. Perform other duties as assigned by Company from time to time which are not specific to Sacrosidase.

Apiscent Labs, Llc

Created and operated cGMP biologic pilot plant. Created and revised SOPs and PMs. Developed process flow diagrams for pharmaceutical products. Managed hazardous and non-hazardous waste disposal. Trained chemical operators on distillation units. Operated Ultra Filtration unit for protein concentrating, reactor vessels (50 gallon to 1,000 gallon), and distillation units (20 liters to 200 gallon).

Coordinate workers in assisting students and faculty members with technology issues. Trouble shoot networking issues and set up/upgrade networking capabilities in academic buildings.