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. Take ownership of the Hospital Site Qualification Program. Take 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

• Required: 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.