Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).
Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU. Omidubicel was being being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive primary and secondary endpoint data reported in 2020.
General Scope and Summary
The Supply Chain Manager is part of the Commercial Supply Chain Operations team. This role is responsible for supporting Gamida Cell commercial operations by managing supply chain execution, activities and responsibilities related to the safe and timely delivery of product(s) to the US commercial market through coordination with manufacturing sites, Gamida Cell Assist and other third parties. Developing and strategically planning logistics, integrations, transportation, and order management solutions that address the needs for the distribution of final product in the US and internationally.
Direct, optimize and coordinate full order cycle; end to end process from cell order through delivery to patient. Liaise and negotiate with suppliers, contract manufacturer(s). Keep track of quality, delivery times, transport costs and efficiency. Resolve any arising problems or complaints. Coach and train Supply Chain team members.
Roles and Responsibilities
- Change of Custody/Change of Identity (COC/COI) – Support compliant execution of the COC/COI of the product(s), deviation management, reconciliation for all COC/COI related events, including SOP’s and other documentation according to the relevant regulations.
- Build end to end supply chain process flow to identify areas for process improvement.
- Management and logistics of sourcing the starting material, Cord Blood Unit (CBU).
- Evaluate and implement business systems for future automation of manual processes.
- Product Logistics – transportation, provision of packaging, temperature compliance, track and trace and external COC/COI execution.
- Order Management – Support designing, maintaining, and managing the operating model order to cash cycle and distribution system.
- Scheduling and capacity – Support managing the scheduling planning/system to ensure adherence to schedule and the highest utilization of capacity.
- Risk mitigation analytics and management.
- Build and manage logistics operations for optimal quality, safety, environmental sustainability, cost-effectiveness, and asset utilization. Coordinate manufacturing plans and evaluate supply chain redundancy needs, ensuring that necessary product manufacturing and distribution backup resources are in place to avoid failure of supply or distribution to the marketplace in the event of a supply chain upset.
- Manage the order management, scheduling, and logistics process for product packaging and shipments.
- Develop, implement, manage, and maintain robust inbound & outbound cold chain logistics processes while maintaining high value product integrity and chain of custody/chain of identity.
- Provide logistical support & expertise product launch and product geographical expansion launches both within the U.S. and internationally.
- Support shipping and transport validation/qualification.
- Manage and support root cause analysis and implementation of corrective actions for logistics deviations and exceptions.
- Work to investigation and resolve international trade compliance issues.
- Work collaboratively with both internal & external partners to achieve business goals.
- Mentor, coach, & develop supply chain team members. as well as other cross functional team members who are new to the field.
Experience, Education and Specialized Knowledge and Skills
- Bachelor’s degree in a related field.
- Minimum of 5 years logistics and supply chain experience is required, ideally in the cell and gene therapy industry and in a complex manufacturing/supply environment with experience in cold chain logistics and good distribution practices.
- 2 years project management experience with knowledge of current PM best practices & tools.
- Understanding of ERP systems as well as strong computer skills and advanced skills in Excel and PowerPoint is necessary.
- Hands on experience in supply chain operations, logistics, materials management, warehouse/ physical distribution, and customer order fulfillment is required.
- Must have global operations experience, import / export operations, working knowledge of regulatory, drug licensing, and operating requirements in a global market.
- Must have experience with global supplier relationship management, contract management & compliance, control, and oversight of contractor / supplier performance.
- Demonstrated ability to build trust/effective relationships/partnerships with peers & stakeholders.
- Effective communication, presentation, decision making, influencing and negotiation skills.
- Excellent people t skills with multicultural background and organizational capability.
- Extensive acumen in problem solving, managing priorities, commitment to quality & safety.
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
- Ability to navigate and be successful in a fast-paced, work environment.
- A passion for addressing the critical unmet medical needs of patients.
- Willingness to embrace/demonstrate the principles of the Gamida Cell culture and values.
Reports to: Director, U.S. Commercial Supply Chain Operations
To apply: Send resume and cover letter to email@example.com.