Principal Validation Scientist
CurrentResponsible for Validation oversight of drug products manufactured at Cambrex manufacturing facility (CDMO) for Clients such that they are manufactured, packaged, analyzed, and released, in accordance with Cambrex policies, procedures, cGMP, and all applicable regulatory requirements.Leads and Manages clients’ portfolio for new product development, technology transfer and commercialization. Ensures successful filing and launch, collaborative relationship with client quality personal and stakeholders. Leads the planning and execution of Process Validation and Cleaning Validation Program, risk analyses, process monitoring, and regulatory inspections. Manages the Cambrex Whippany site Validation Master Plan for legacy and new formulation product launches in support of Commercial Manufacturing and Product Development.