Chris is a great Quality Lead for any start-up life sciences company.
Chris has worked for several bio/pharma start-up companies. In some cases, the Quality laboratories did not have any equipment, or the business site had not experienced their first audit. He was responsible for building Quality Control/Assurance departments, determining organizational structure, hiring teams and product manufacturing planning. This resulted in successful regulatory audits to obtain GMP manufacturing certificates, site commercial manufacturing, and approval to distribute medicinal products to targeted markets.
Start-up companies always face the challenge of working with limited resources. In start-ups, Chris assisted with hiring general contractors to perform all new equipment purchasing, intake, IQ/OQ/PQ, and he managed equipment calibration timelines, with QC/QA oversight and approval of all contractor activities. In addition, he contributed to hiring FTE laboratory personnel to establish essential laboratory workflows and processes such as 6S, Kanban, housekeeping, glass washing, gowning, storage unit alarm response, sample management and quality systems (deviations, investigations etc.). He also created lab work instructions (SOP’s and Protocols), enabling the companies to perform transfer work once new equipment were GMP released for use and prepared for commercial manufacturing.