Sr. Manager, Manufacturing Quality Sciences (Upstream)
Professional with 10 years of experience in the Biopharmaceutical Industry working in all aspects of product development from upstream and downstream bioprocess development to analytical methods development. I spent 8 years in Process Sciences developing CHO based upstream processes for transfer into cGMP which included subcloning of stable pools, medium and feed screens, small scale bioreactors for process testing and scale up to MFG. My upstream focus in manufacturing is the use of single use technology utilizing Thermo, Sartorius, Excellerex and Millipore single use bioreactor systems.I have also developed downstream purification processes for research grade antibodies for animal testing. This included protein A for affinity capture, cation exchange, anion exchange and CHT for polishing steps. My analytical expertise includes ELISAs and HPLC along with numerous other assay methods such as SDS-PAGE, western blot, micro BCA and protein concentration using spectrophotometry. My ELISA experience includes binding assays, titer in cell culture supernatant, PK assays and impurity assays including residual HCP and residual protein A. HPLC methods include protein A titer, size exclusion and weak cation exchange. About 2 years ago, I transitioned to the Manufacturing Quality Sciences department for Upstream. My current duties include; providing quality and SME oversight on the floor during critical manufacturing processes, troubleshooting incidents that occur and provide guidance on how to proceed with the process, writing deviation and investigation reports which require root cause analysis and product impact statements, lead upstream process validation activities, and lead cross functional teams between Process Sciences, Quality, and Manufacturing to perform tech transfers of new processes.
