Andy Fankhauser Email & Phone Number

Salt Lake City, Utah, United States

Manage 30+ personnel working in bulk, aseptic filling, and finishing production departments, including the managers of each department and all contracted personnel.Regulate the flow of contracted personnel to meet target inventory levels of bulk, bright stock, and finished products.Track, analyze and maintain target efficiency levels that meet or improve the standard costs for direct labor production rates.Project manage new capital projects and continuous improvement initiatives, from the creation of business plans to implementation according to ISO 13485 quality standards.

Salt Lake City

-Led cross-functional teams in the successful planning, execution and delivery of various projects, ranging from facility design and buildout to new product development efforts-Developed and maintained project plans, including project objectives, timelines, and deliverables-Monitored project quality standards, conducted quality inspections, and implemented continuous improvement initiatives to enhance project outcomes-Conducted comprehensive risk assessments, developed risk mitigation strategies, and executed contingency plans to ensure project success in dynamic environments

Greater Salt Lake City Area

Responsible for the organic synthesis, aseptic processing, and QC testing of wound-healing biomaterials. Successfully doubled the batch size of corneal gel using historical data and stoichiometry with no loss of product. Responsible for the continued scale-up of manufacturing processes, review and approval of all batch records, and the creation of customer-specific certificates of analysis. Knowledge of ISO 13485 standards.

Greater Salt Lake City Area

Responsible for the organic synthesis of wound-healing biomaterials, including aseptic processing in ISO 7 and ISO 5 regulated areas. Performed and documented all QC testing and activity. Updated batch records and processes to meet product specifications. Manufactured corneal wound-healing gel under GMP regulations for human clinical trials.

Provo, Ut

Literary research, data compilation, and critical evaluation of thermodynamic properties for specific compounds. Experimental work using Differential Scanning Calorimetry and Gas Chromatography/Mass Spectrometry.

West Valley City, Ut

Evaluated quality assurance procedures for efficiency. Ensured customer specifications were accurate and up-to-date. Designed digital work flow for new specification updates.