Owning all quality related responsibilities for the CQV Lifecycle Program for new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs;...
Leads a team of Group Heads and Scientists. Ensures process development stages for liquid and lyophilized parenteral drug products (DP) of biologics (e.g. monoclonal antibodies,...
Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product...
Responsible for managing daily activities related to quality, including campaign preparation, change control, deviation & CAPA management, and process monitoring. Ensures...
Play a key role supporting the BLA track of a late-stage drug substance (DS) manufacturing process at an external manufacturing partner (CMO) to enable process qualification and...