Adam R Day

Background

About Adam R Day

I am a Bioprocess Engineer with extensive experience in Upstream Process Development, Tech Transfer, and GMP Manufacturing. I received my BS and MS in Biochemical Engineering as well as a graduate certificate in Biochemical Regulatory Engineering from University of Maryland Baltimore County. I currently hold the position of Senior Manager of Manufacturing Operations at BioFactura Inc. overseeing all upstream manufacturing operations and assisting the Associate Director of Manufacturing Operations with oversight of the downstream processes. In this role I coordinated work over 3 shifts for 24-hour coverage during manufacturing campaigns, while working shifts on the floor. The size of the company (<50) drove the necessity to take on roles beyond that typical of a traditional Manufacturing Operations Manager. Examples of these roles include Tech Transfer (both internal from PD into Manufacturing and external to strategic partners), Supply Chain Management, and Process Development (both at the bench and at scale development). My first role within the company (for 3 years) was in Process Development where I learned several suspension bioreactor systems (Cytiva, Eppendorf, and Sartorius AMBR15) and developed and implemented the Repligen ATF perfusion system to further increase our yields. When I transferred into manufacturing, I helped bring our manufacturing capabilities from pre-clinical to phase I clinical manufacturing. This effort included the authoring of a wide array of GMP documents including work instructions, batch records, material specifications, process descriptions, and supporting forms.A highlight of my tenure at my current company is the at scale development of a dCO2 control loop to address CO2 accumulation issues encountered upon scale up. The implementation of the control loop allowed for increases in cell density and titer by a factor of 5. The strategy has been implemented across all at scale manufacturing processes at both the 200 L and 500 L scales. Another highlight is the successful tech transfer of our upstream manufacturing process to a strategic partner company in India. I took part in tech transfer meetings and oversaw the execution of bench scale improvement runs both here and in India to boost yield and reduce cost of goods sold. This effort culminated in a trip to India to oversee the first at scale engineering run for our lead biosimilar asset.I am a hands on and eager learner whose broad range of skills make me a unique candidate.