n\n Trade compliance and cross-border enablement: ensure that all supply chain activities comply with global export/import regulations and customs requirements, enabling compliant cross-border movement of GMP materials across both clinical and commercial supply chain.\n \n\n Oversee integration of trade compliance into Bicara's outsourced operations, including product classification, valuation, and country-of-origin determination, import-export licensing, customs brokerage oversight and regulatory agency engagement, duty optimization strategies in partnership with relevant functions.\n \n\n \n\n General\n Operate as a cross-functional enterprise leader with accountability for outcomes across Bicara's outsourced network and internal stakeholders.\n \n\n Balance strategic design with hands-on operational oversight, stepping into tactical issues when required to protect supply continuity.\n \n\n Demonstrates ability to influence without direct-line management authority across internal and external ecosystem.\n \n\n Treat external partners (3PL, CMOs, CPOs, Serialization) as extension of the enterprise supply chain rather than just transactional suppliers.\n \n\n Align supply chain decisions with broader enterprise priorities while translating complex supply chain dependencies into clear business trade-offs for executive stakeholders.\n \n\n Actively contributes to Bicara's BLA readiness planning from a supply chain perspective, ensuring that packaging, serialization, and logistics requirements are fully integrated into the company's regulatory submission and commercial launch strategy.\n \n\n \n\n \nQualifications\n\n Bachelor's degree in Business, Supply Chain, Engineering, or a closely related field is required. \n\n Ensures alignment of all packaging components and processes with regulatory filings, specifically Bicara's first BLA submission, such as compliance of container closure systems, adherence to approved labeling as defined in regulatory submissions including strict change control and variation management, oversight of packaging validation and process qualification to meet regulatory expectations for commercial launch readiness.\n \n\n Establishes and maintains robust artwork governance, label control process and change management in collaboration with Regulatory Affairs and Quality to ensure continued alignment with approved filings for BLA and ex-US dossiers.\n \n\n Drives the design and implementation of tamper-evident, anti-counterfeiting, and patient safety features across all commercial products.\n \n\n Manages the CMO relationship \u2013 meets regularly to monitor performance, manage materials, and ensure adherence to packaging schedule.