Manager​/Sr. Manager, Commercial Logistics

Job Title: Manager/Sr. Manager, Commercial Logistics

Job Number: 37263

Location: ,CA 92121

The Sr. Manager / Manager of Commercial Logistics is responsible for leading end-to-end commercial distribution operations for Capricor’s drug products. This role oversees GxP-compliant logistics, cold‑chain distribution, third‑party logistics (3PL) management, serialization, and DSCSA compliance. The position ensures products are stored, handled, serialized, and delivered to customers, partners, depots, and distributors in full alignment with regulatory and quality requirements.

This leader will partner cross-functionally with Supply Chain, Quality, Commercial, Manufacturing, CMC, and external logistics and serialization partners to build and manage robust commercial distribution and compliance processes that support product launch and commercial growth.

• Lead day-to-day oversight of commercial distribution activities for drug product shipments (domestic and international).
• Manage commercial cold‑chain distribution, ensuring product integrity, temperature‑controlled packaging, lane qualification, and monitoring.
• Develop and maintain logistics processes for order fulfillment, shipment tracking, delivery confirmation, and exception handling.
• Ensure all activities comply with GDP/GxP, FDA/ICH regulations, and internal SOPs.
• Oversee the receiving, collection, and handoff of finished goods (FG) from manufacturing, including flexible hour coverage as required to support real‑time production and release schedules.

• Manage assembly components required for commercial pack‑out, including storage, issuance, staging, and reconciliation of all packaging materials.
• Coordinate with Quality, Packaging Vendors, Manufacturing, and 3PLs to ensure pack‑out kits are complete, compliant, and available when needed.

• Serve as the primary operational lead for 3PLs, couriers, packaging providers, and commercial distribution partners.
• Monitor 3PL performance via metrics, QBRs, and contract commitments.
• Manage distribution agreements, service levels, capacity planning, and cost control.
• Lead issue resolution for shipment deviations, temperature excursions, and supply disruptions.

• Own and govern end-to-end serialization and DSCSA business processes across packaging, distribution, and trading partners, ensuring compliance with U.S. and international regulatory requirements and internal quality standards.
  • Act as the primary business lead for serialization systems and data flows (e.g., product identifiers, aggregation, EPCIS).
  • Partner closely with IT, Quality Engineering, Supply Chain, and external serialization vendors to drive system maintenance, issue resolution, and continuous improvement.
  • Monitor regulatory changes, compliance metrics, and operational performance related to serialization and DSCSA obligations.
  • Lead deviations, investigations, and remediation activities for serialization, EPCIS data, system failures, and DSCSA compliance gaps.
  • Collaborate with IT and Supply Chain to ensure accurate ERP configuration, data integrity, and process alignment for order management, inventory control, distribution workflows, and serialization integration.
• Launch Readiness & Commercial Expansion
  • Support global launch planning, including route‑to‑market strategy, depot set‑up, trade/distribution model design, and packaging/labeling logistics.
  • Build scalable processes to support product growth, new indications, and geographic expansion.
  • Collaborate with Commercial and Finance to develop demand forecasts and distribution plans.
• Compliance, Documentation & Quality Support
  • Maintain GDP‑compliant documentation, including shipping records, temperature logs, investigations, and change controls.
  • Partner with Quality to support audits, lot release logistics, and inspection readiness.
  • Author and maintain shipping, distribution, and serialization SOPs and training materials.
  • Ensure that all onboarding, receipt, and control of packaging components, pack‑out materials, and finished goods follow…