Senior Director, Supply Chain

Our innovative biotech partner in San Mateo County is looking for a talented Senior Director of Supply Chain to establish and lead supply chain and distribution as they prepare for commercial launch of programs. The biotech is a lean, virtual organization and has a global CDMO network. They work on rare disease areas for metabolics and have a veteran leadership team.Responsibilities:Lead and manage the global clinical supply chain to ensure continuous supply for patients, lay the foundation and build the commercial supply chain organization including distribution networks for rapid accessPartner with Quality and other groups to establish and maintain the inventory management system and lead in executing the validation master planBuild logistics and trade compliance functions and implement serialization platform to meet regulatory standardsCollaborate with partners across CMC, Clinical teams, and external partners in support of CMC activities including regulatory submissions, inspections, and queriesSupport vendor qualification process and capability assessmentRequirements:Advanced degree with a minimum of 10 years of industry experience in a highly regulated pharma/biotech supply chain position - ideally in biologicsExperienced in managing multiple phase 3 studies, transitioning supply chain functions from clinical stage to commercial launch is highly preferredExperienced in using NetSuite and leading on design and implementation of electronic inventory systems, global serialization experience using EPCIS systems and Tracelink are preferredDemonstrated experience in leading of US and EU distribution networks besides a history of experience within cGMP and global regulatory standardsYou are a successful supply chain leader within small biotechContact Information:Please reach out to amit@peoplewithchemistry.com or 628-336-2772. Our communications will be confidential.

#J-18808-Ljbffr