Expertise in multiple cell culture techniques: stirred-tank bioreactors
batch/ fed-batch/ continuous in manufacturing. • Extensive bioreactor experience across multiple scales – WAVE Bags(5 L to 50 L)
20 L bioreactors
SUBs (50 L to 2000 L)
and stainless steel bioreactors (2000 to 15000+ L). • Experience with Upstream New Production Introduction (NPI) to support clinical manufacturing. • Led cross-functional CMC team collaboration within internal and external clinical / commercial manufacturing organizations to support site goals and technical program advancement. • Experienced in managing complex projects with diverse teams
fostering collaboration • Led virtual technical transfers to multiple sites to support successful manufacturing of early
late
and commercial phase biologics. • Extensive software training in MS Office
Spotfire
TrackWise (Deviation
CAPA
Change Management)
and DeltaV