Senior Director, Commercial Packaging, Serialization and Global Logistics
Bicara Therapeutics
June 30, 2026
Remote friendly (Boston, MA)
United States
$265,000 - $316,000 USD yearly
Operations
Responsibilities:
- Commercial Packaging: Lead commercial packager selection; manage RFP, partner selection, contracting, qualification, and ongoing performance management. Ensure packaging design/artwork/labeling meet regulatory and global compliance while meeting commercial objectives. Drive commercial packaging for future BLA submission and market launches. Ensure alignment with regulatory filings (container closure systems, approved labeling, strict change control/variation management, packaging validation and process qualification). Establish artwork governance/label control/change management with Regulatory Affairs and Quality. Drive tamper-evident, anti-counterfeiting, and patient-safety features. Manage CMO relationship, packaging schedule, and packaging budget/invoicing.
- Serialization: Own global serialization strategy and system architecture with internal IT and external partners; oversee partner integration/governance. Ensure serialization readiness and lifecycle management aligned to track-and-trace regulations. Oversee provider/technology selection, contracting, qualification, and performance, including unit serialization and aggregation commissioning/decommissioning. Establish serialization SOPs for audit readiness. Collaborate with IT, Quality, Regulatory to support patient safety, anti-counterfeiting, returns management, and uninterrupted supply.
- Global Logistics: Own global functional strategy/operational oversight for clinical and commercial cold-chain GMP shipments. Own cold-chain strategy and execution (qualification, validation, monitoring, lane/system optimization). Manage internal/external partner relationships. Lead selection/qualification/contracting/performance management of US 3PL for outsourced Order-to-Cash. Ensure trade compliance and cross-border enablement; integrate trade compliance into outsourced operations (classification, valuation, country-of-origin, licensing, customs brokerage oversight, agency engagement, duty optimization).
Qualifications:
- Bachelor’s degree in Business, Supply Chain, Engineering, or related field (advanced degree preferred).
- 12+ years progressive supply chain experience in global logistics, trade compliance, commercial packaging, serialization, and 3PL oversight in life sciences.
- Deep understanding of GMP/GCP/GDP and applicable global regulations; functional knowledge of trade compliance.
- Senior leadership experience in a virtual biotech with complex global external partner networks.
- Cold-chain logistics experience (2–8°C and frozen) for biologics/temperature-sensitive products.
- Adaptable in fast-paced cross-functional environment with evolving priorities.
- Strong financial acumen (planning, budgeting, financial KPIs).
- Commercial Packaging: Lead commercial packager selection; manage RFP, partner selection, contracting, qualification, and ongoing performance management. Ensure packaging design/artwork/labeling meet regulatory and global compliance while meeting commercial objectives. Drive commercial packaging for future BLA submission and market launches. Ensure alignment with regulatory filings (container closure systems, approved labeling, strict change control/variation management, packaging validation and process qualification). Establish artwork governance/label control/change management with Regulatory Affairs and Quality. Drive tamper-evident, anti-counterfeiting, and patient-safety features. Manage CMO relationship, packaging schedule, and packaging budget/invoicing.
- Serialization: Own global serialization strategy and system architecture with internal IT and external partners; oversee partner integration/governance. Ensure serialization readiness and lifecycle management aligned to track-and-trace regulations. Oversee provider/technology selection, contracting, qualification, and performance, including unit serialization and aggregation commissioning/decommissioning. Establish serialization SOPs for audit readiness. Collaborate with IT, Quality, Regulatory to support patient safety, anti-counterfeiting, returns management, and uninterrupted supply.
- Global Logistics: Own global functional strategy/operational oversight for clinical and commercial cold-chain GMP shipments. Own cold-chain strategy and execution (qualification, validation, monitoring, lane/system optimization). Manage internal/external partner relationships. Lead selection/qualification/contracting/performance management of US 3PL for outsourced Order-to-Cash. Ensure trade compliance and cross-border enablement; integrate trade compliance into outsourced operations (classification, valuation, country-of-origin, licensing, customs brokerage oversight, agency engagement, duty optimization).
Qualifications:
- Bachelor’s degree in Business, Supply Chain, Engineering, or related field (advanced degree preferred).
- 12+ years progressive supply chain experience in global logistics, trade compliance, commercial packaging, serialization, and 3PL oversight in life sciences.
- Deep understanding of GMP/GCP/GDP and applicable global regulations; functional knowledge of trade compliance.
- Senior leadership experience in a virtual biotech with complex global external partner networks.
- Cold-chain logistics experience (2–8°C and frozen) for biologics/temperature-sensitive products.
- Adaptable in fast-paced cross-functional environment with evolving priorities.
- Strong financial acumen (planning, budgeting, financial KPIs).