Corey Parks Leaders
I am a results driven scientist with an engineering background and proven track record of success working in the fast paced biologics development environment. I know that the details can often mean the difference between success and failure. My motivation, technical expertise, inspiration, and keen attention to detail have allowed me to make meaningful contributions for the projects that I have been involved with thus far in my career. Strong communicator and able to succinctly summarize data-driven conclusions & propose strategy for various stages of projects by effectively tailoring messages to audiences including senior leaders.
Lead development efforts and supported process and technology transfer for 14+ drug substance programs into cGMP environments for clinical production at the 2,000L manufacturing scale including REGN-COV™ (casirivimab and imdevimab), Dupixent®(dupilumab), Eylea®(aflibercept), Evkeeza®(evinacumab-dgnb), Inmazeb™(atoltivimab, maftivmab, and odesivimab - ebgn), mibavademab (REGN4461) and itepekimab (REGN3500). As part of program maturation and preparation for the Biological License Application (BLA), lead development and technology transfer for 4+ additional programs with fully mapped out characterized processes linking raw materials and critical process parameters (CPPs) to pre-defined critical quality attributes (CQAs) and process attribute goals establishing process control strategies. Provided guidance for additional pre-validation risk mitigation activities such as Failure Mode Effect & Analyses (FMEA) & Normal Operating Range (NOR) & Proven Acceptable Range (PAR) study designs prior to Process Performance Qualification (PPQ) campaigns.
Possess broad range of downstream and purification expertise through acquired skill sets gained throughout 9+ years of industrial biotechnology process development experience. Strong theoretical understanding of core fundamentals required for various applications of differentiated purification techniques including product capture and isolation, impurity separation and most filtration operations typically used for manufacture of biological drug substances.
