Supply Chain, Sr. Manager/Associate Director – Bluebird Bio – Cambridge, MA, USA
We seek an entrepreneurial and highly motivated supply chain professional with broad clinical/commercial supply chain management expertise to help build and lead our planning/scheduling function. This position works closely with internal teams, external vendors and suppliers to ensure materials are available to meet manufacturing, testing, and clinical trial objectives.
About the role:
Responsible for developing, establishing and manage the Planning/Scheduling function. Work closely with Clinical Operations and CMOs along with other contracted service providers to assure seamless operation of clinical trials and eventual commercial supplies.
Responsible for developing and executing supply plans for all phases of clinical studies and future commercial supply, requiring understanding of GXP, planning/scheduling, inventory management, Investigational Medicinal Product (IMP) and logistics.
Coordinate with clinical site study coordinators, cell collection centers, cell therapy manufacturing sites and internal stakeholders to ensure study subject schedules are maintained within the process and logistic constraints.
Develop tools for production planning, volume & capacity studies, and participate in process improvement efforts and other risk mitigation and efficiency efforts.
Oversight of multi-stage inventory planning, from raw materials through Drug Product in coordination with Manufacturing, Clinical/Commercial Operations and Quality Assurance.
Develop and implement planning tools through MS Project, spreadsheet and relational databases for supply chain and operations teams.
Create consensus demand forecasts and aggregate forecasts as appropriate for input into planning model.
Pro-actively run situational analysis and build scenarios to address specific demand and supply constraints.
Identify risks associated with meeting the inventory strategies and develop contingency plans around that risk as needed.
Manage supply relationships with internal and external stakeholders. Investigate and recommend new and improved planning systems and processes and identify risks in supply chain; recommend mitigation plans and implement solutions. Ensures policies are established and drives quality improvements and initiatives related to supply chain management.
Develop and manage lot use strategies with Manufacturing, Regulatory and Quality; ensuring CMC changes are approved as needed to enable lot use in the targeted countries.
Responsible for packaging & labeling activities; generation and implementation of new and revised artwork/labels for multiple products, CMO sites and countries worldwide.
Partner with Director, Supply Chain to develop and formally document supply strategy and processes.
Bachelor’s Degree or equivalent (advanced degree preferred)
8 or more years in a related supply chain/procurement/logistics/sourcing role with at least 4 leading the function.
Prior employment at a biotech or pharmaceutical company in similar role.
Experience managing complex schedules and priorities in dynamic environments.
Experience in overall planning, demand forecasting/supply planning, and corporate planning
Experience with cGMP, biologics, cold chain, cell therapy, and/or clinical operations highly preferred.
Proficient in MS Word, Excel, Power Point, Visio, Project, ERP and other applications
Experience with ERP systems including working with user requirements and implementation teams.
Ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself