・ Leads CMC readiness and risk management for all launches and major supply chain changes; ensuring integrated project plans are in place and executed.
・ Manage development of Launch, Lifecycle Management, and/or Supply Capability Implementation Plans.
・ Actively participate in appropriate Commercial Launch, Strategy, and Program Teams
・Monitors and reports CMC impact to Supply Chain Plans and product supply to ensure right product, right place, and right time. Present data, impact, and mitigation steps as necessary in formal meetings or as necessary.
・ Assess regulatory impact of CMC changes to licensed products or clinical trial applications
・ 5-10 years pharmaceutical/biotechnology industry experience.
・ BA/BS/University degree required, Life/Health Sciences preferred
・Graduate degree preferable