Supply Chain Associate

Role Summary

Supply Chain Associate

Responsibilities

• Hospital Site Qualification: Facilitating in site audits to assess readiness and compliance with study protocol; organizing and facilitating study training sessions with hospital site staff; planning and overseeing dry runs to test operational workflows, trial logistics, and data collection processes; managing ongoing hospital site maintenance; taking ownership of the Hospital Site Qualification Program; taking lead on any immediate actions, corrective actions, investigations, or issue resolution related to hospital site operations.
• Stakeholder Collaboration: Collaborate closely with cross-functional teams to ensure seamless site qualification and trial execution.
• Patient Logistics: Coordinate scheduling for apheresis collection and investigational product deliveries; collaborate with third-party logistics vendors on shipping and packaging needs; support patient communication planning regarding timelines and logistics; oversee reconciliation of Chain of Identity (COI), Chain of Custody (COC), and transportation documentation.
• Manufacturing Materials Management and Operations: Support the monitoring and tracking of raw material and consumable inventory levels; drive the planning and execution of purchase orders; maintain and update the Item Master in ERP systems; collaborate with suppliers to confirm lead times, resolve delivery issues, and support quality and compliance expectations; participate in material receipt, inspection, and release processes to ensure conformance to specifications and GMP standards; identify and address material shortages, excesses, and expiration risks through proactive inventory analysis and reporting.

Qualifications

• Minimum of 5 years of experience in biotech, pharmaceutical, or cell therapy industries.
• Experience in clinical trial operations.
• Experience in supply chain logistics.
• Strong vendor management and cross-functional communication skills.
• Proficiency in managing hospital site or clinical staff relationships.
• Demonstrated ability to work independently in a startup or fast-paced environment.

Preferred

• Experience with GMP procurement, sourcing, and systems (e.g., NetSuite, SAP).
• Familiarity with COI/COC documentation and patient-specific logistics.
• Experience writing or maintaining SOPs and GMP documentation.
• Strong organizational and report development skills.