Manager / Senior Manager, Commercial Logistics

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

Capricor is seeking a Manager or Senior Manager of Commercial Logistics to lead the day-to-day operational execution of commercial distribution activities for our growing portfolio. This individual will oversee GxP‑compliant logistics, cold‑chain distribution, serialization and DSCSA processes, and 3PL partnerships that support product launch readiness and ongoing commercial operations. This role is critical as Capricor transitions from clinical-stage to commercial-stage operations and scales its distribution capabilities globally.

Responsibilities:
• The responsibilities of this job include, but are not limited to:

Commercial Distribution & Logistics Management
• Lead daily commercial distribution operations for domestic and international drug product shipments, ensuring product integrity and on-time delivery.
• Oversee cold‑chain logistics, including temperature‑controlled packaging, lane qualification, and excursion management.
• Manage order fulfillment, shipment visibility/tracking, delivery confirmation, and exception handling processes.
• Ensure full compliance with GDP/GxP, FDA/ICH guidelines, and internal SOPs.
• Oversee receiving, handoff, and flow of finished goods from manufacturing, including flexible coverage to support real-time production schedules.

Packaging Components & Pack-Out Operations
• Manage all commercial packaging components, including storage, issuance, staging, reconciliation, and pack-out readiness.
• Partner with Manufacturing, Quality, packaging vendors, and 3PLs to ensure compliant and timely pack-out operations.
• 3PL & External Vendor Oversight
• Serve as primary operational lead for 3PLs, couriers, and commercial distribution partners.
• Monitor partner performance (KPIs, QBRs, service levels), escalate operational issues, and ensure adherence to contractual commitments.
• Lead resolution of shipment deviations, temperature excursions, and supply disruptions.

Serialization & DSCSA Compliance
• Own serialization and DSCSA processes across packaging, distribution, and trading partners, including EPCIS data flow oversight.
• Lead investigations and remediation for serialization issues, EPCIS failures, and DSCSA compliance gaps.
• Partner with IT, Quality Engineering, and external serialization vendors to maintain system performance, data integrity, and regulatory alignment.

Launch Readiness & Commercial Expansion
• Support route‑to‑market design, depot setup, packaging/labeling logistics, and readiness activities for U.S. and global launches.
• Build scalable processes to support new indications, increased commercial volumes, and geographic expansion.
• Collaborate with Commercial and Finance functions on demand forecasts and distribution plans.

Compliance, Documentation & Quality Support
• Maintain GDP‑compliant records including temperature logs, shipping documentation, investigations, and change controls.
• Support Quality in audits, inspections, and lot‑release logistics.
• Author and maintain SOPs for shipping, distribution, and serialization.

Operational Excellence
• Analyze logistics and serialization performance metrics to identify improvement opportunities.
• Implement best practices in cold‑chain technology, packaging, freight optimization, and risk mitigation.

Requirements:
• Education: Bachelor’s degree in Supply Chain, Business, Life Sciences, Engineering, or related field.
• Experience: 6+ years pharmaceutical/biotech logistics and distribution experience, including cold‑chain operations and GxP/GDP compliance.
• Technical Expertise: Hands‑on expertise in serialization and DSCSA (EPCIS, aggregation, product identifiers).
• Vendor Management: Proven experience managing 3PLs and commercial distribution centers.
• Systems: ERP experience (NetSuite, SAP, Oracle) with distribution, inventory, or order management workflows.
• Skills: Strong analytical, communication, cross‑functional collaboration, and problem‑solving skills.

Preferred Qualifications:
• Experience: Supporting commercial product launches in pharma/biotech.
• Knowledge: Cell therapy, gene therapy, or complex biologics distribution.
• Familiarity: Import/export, global distribution, and customs processes.
• Certification: Project management certification or experience (e.g., PMP).
• Technical Experience: Advanced ERP/WMS and serialization tools, including EPCIS data analysis.

Why Capricor?
Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.

Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.