Associate Director, Supply Chain - Cambridge , Massachusetts, United States, 02140
- Technical proficiency in commercial supply chain technologies and processes including serialization as well as in related pharmaceutical regulations for commercial distributions.
- Demonstrated experience in building-out a commercial product supply chain to enable product launch and translating demand to a rolling supply forecast and firm production orders to sustain supply, in conjunction with CMO's, within a cGMP-regulated environment.
- Manage end to end clinical and commercial supply planning process including but not limited to shelf life extension, bulk drug product manufacturing, scenario planning and inventory movement.
- Develop integrated plans to ensure uninterrupted supply of material, such as regulatory starting materials, bulk drug substance and product, finished goods for clinical trials and commercial demand.
- Collaborate with Operations Management to ensure the commercial supply. Lead the monthly sales and operations planning (S&OP Meetings) by conducting the necessary analysis and preparing the appropriate reports, working collaboratively with Commercial Teams.
- Commercial and clinical inventory management including managing global depot inventory supporting clinical studies. Review inventory reports and prepare inventory balance changes to accurately reflect the flow of materials, ensuring lot trace ability.
- Lead cross-functional team meetings, including Operations Management, Technical Operations, Process & Controls Development, Clinical Operations, Strategic Sourcing, Quality Assurance and Regulatory teams, to ensure clinical and commercial supplies status is being communicated.
- Assess, manage, and track the purchase, distribution and labeling of comparative products and other miscellaneous ancillary clinical trial material.
- Ensure that key project milestones are met; negotiates and communicates supply plan timelines within CMC Operations and with external partners.
- Bachelor's degree with 7+ years of experience with a minimum of 2 years within a clinical and/or commercial supply chain function in a biotech or pharmaceutical environment and
- Associate's Degree with 12+ years of experience with at least 4 years in a biotech or pharmaceutical environment
- 15 years of work experience within a clinical and/or commercial Supply Chain function in a biotech or pharmaceutical environment
- Prior Cold Chain distribution experience.
- Working knowledge and experience with ERP and Quality systems required
- Experience in vendor oversight and managing external partnerships and relations.
- Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP).
- Experience in deviation investigation and CAPA implementation.