**Seeking candidates in the Bay Area**
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 access
- Partner with Quality and other groups to establish and maintain the inventory management system and lead in executing the validation master plan
- Build logistics and trade compliance functions and implement serialization platform to meet regulatory standards
- Collaborate with partners across CMC, Clinical teams, and external partners in support of CMC activities including regulatory submissions, inspections, and queries
- Support vendor qualification process and capability assessment
Requirements:
- Advanced degree with a minimum of 10 years of industry experience in a highly regulated pharma/biotech supply chain position - ideally in biologics
- Experienced in managing multiple phase 3 studies, transitioning supply chain functions from clinical stage to commercial launch is highly preferred
- Experienced in using NetSuite and leading on design and implementation of electronic inventory systems, global serialization experience using EPCIS systems and Tracelink are preferred
- Demonstrated experience in leading of US and EU distribution networks besides a history of experience within cGMP and global regulatory standards
- You are a successful supply chain leader within small biotech
