Patrick Larson Email & Phone Number

Golden, Colorado, United States

Westminster, Colorado, United States

As part of a startup company in the hemp extraction and CBD dietary supplement space I managed the development and implementation of the necessary food safety and quality management systems. Led project to prepare facilities and operation for GMP and Hemp Authority certifications. Worked with manufacturing to update all master manufacturing and batch production records for 21 CFR 111 compliance. Collaborated with product development team and marketing on formulation changes and new product branding for packaging and labeling compliance.

Durango Colorado

Managed the day-to-day commercial aspects of the factory Quality, Safety and Compliance Operations. Development and implementation of the site quality management system to comply with Food Safety and GMPs and recommend strategies for overall product quality improvements. Managed all state, federal agency and 3rd party audits and inspections. Conducted regular Food Safety/cGMP internal audits and follow up for corrective actions. Lead root cause investigations for product quality issues and customer complaints and establishing effective corrective action plans to improve product quality, safety and overall compliance.

Golden Co

Improved and maintained the site quality management system for ISO 9001, 17025, 17034 and 17043 certifications and accreditation. Managed all agency and customer audits as well as conducting internal program audits. Coordinated, compiled, and presented site quality metric data to corporate leadership through quarterly management review meetings. Worked with operations to identify root cause and the implementation of effective corrective actions to reduce failures and improve product quality.

Managed the day-to-day operations for the manufacturing and distribution of radiopharmaceutical drug products and raw materials. Managed completion of all projects within the manufacturing, customer service, shipping, warehouse, radiation safety and compliance departments. Maintained existing vendor relations for manufacturing and product distribution services. Responsible for the development and execution of manufacturing process validations. Ensure operational compliance to cGMP, IATA, DOT, NRC, CDPHE, EPA, OSHA, and multi-state manufacturing & wholesale distribution licensing.

Managed compliance of approximately 16 Positron Emission Tomography (PET) manufacturing facilities to cGMPs, aseptic drug guidelines, aNDA and standard operating procedures. Responsible for the management of all FDA inspections in my region and respond to any deficiencies identified.

Aurora, Colorado, United States

QA oversight of 6-8 Positron Emission Tomography (PET) manufacturing facilities during the transition to cGMP compliance (21CFR212). Managed all quality issues and investigations for the drug products manufactured at each facility. Management of the site quality department including hiring and development of personnel. Led all FDA inspections and IND sponsor audits as well as corrective action plans for identified deficiencies. Authored, reviewed and approved all quality system procedures, policies and test methods.

Aurora, Co

Maintained the radiation safety program to meet CDPHE and NRC regulations. As calibration program manager I oversaw the company wide calibration program for 150+ nuclear pharmacies to ensure quality assurance and accuracy of radiopharmaceutical dose measurement. Developed test methods and standard operating procedures for the centralized radionuclide purity analysis of FDA regulated products.