This role will oversee and manage Genocea’s Supply planning and logistics for personalized medicine. This includes but not limited to communicating supply plans based on clinical demand; Partnering with other functions to support development of COGS models and associated analytics to drive continuous improvements initiatives; key point person for Pharma Sci to manage and maintain production schedules and, budgets as well as evaluate and develop long and short term supply scenarios. This position will also be responsible for managing CMO/CRO relationship with global storage and logistics partner including inventory management for GMP materials including personalized drug substance, drug product and finished goods.
Communicate regularly with program team and e-team to track risks and mitigations, updates in PM tracking systems, project management gaps
Meet with functional lead to discuss day to day operations and track progress on Program deliverables and ensure that action items are being addressed in a timely manner. Summarize and report progress to Program Lead and leadership as requested.
Responsible for overall management of production schedules, forecasting and end-to- end supply chain planning.
Deliver robust and comprehensive supply models; Identify risks and constraints to achieving supply.
Build and maintain communication channels among all groups associated with the Supply Chain through information sharing, thought leadership, and tactical and strategic planning
Generate reports for project documentation for internal/external communication (written reports, presentations etc.) to various functions including senior management.
Ensure successful and timely delivery of all project deliverables within area of responsibility
Solid experience in Supply Chain function with knowledge of S&OP, global logistics and management of CRO/CMOs.
Strong analytical and problem-solving skills with strong attention to detail
Knowledgeable in biologics processes/cycle times for drug substance, drug product, secondary packaging and labeling.
Ability to work with cross-functional teams to develop and support long range planning efforts (scenario planning and analytics for impact assessments)
Experience in and/or a solid understanding of inventory management (drug substance, drug product, etc.)
Experience with CMC teams, as a lead or a team member
Demonstrated experience managing GMP operational and business activities at CROs/CMOs
Knowledge of global trade compliance landscape (local and regulatory) as well as experience with import/export requirements for pharmaceutical/biotechnology products at clinical and commercial stage.
Expertise in supply chain software.
Education & Experience
A B.S. degree in business or a scientific discipline with 10+ years of experience, MBA preferred.
5+ years of global supply chain experience in the area of supply planning and/or logistics for pharmaceutical clinical and commercial products.