Manager / Senior Manager, Commercial Logistics

Job Description

Job Description

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.

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.

Responsibilities

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

Commercial Distribution & Logistics Management

• 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.

Assembly Components & Pack-Out Management

• 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.

3PL / External Partner Oversight

• 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.

Serialization & DSCSA Compliance

• 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 company inventory policies and are fully aligned with ERP/serialization tracking requirements.

Operational Excellence & Continuous Improvement

• Analyze logistics and serialization performance metrics to identify improvement opportunities.
• Implement best practices across packaging, freight optimization, cold-chain technologies, and distribution risk mitigation.
• Support business continuity planning and supply chain resilience initiatives.

Team Management

• Directly supervises the Commercial Logistics Supervisor and Shipping Associates responsible for daily shipping, receiving, and finished goods handling.
• Provides coaching, development, and performance management to logistics team members.
• Oversees workload planning, training, and staffing to support commercial operations.
• This team will expand as commercial volumes grow, and the Sr. Manager/Manager will lead future hiring and organization development.

Requirements

• Bachelor’s degree in Supply Chain, Business, Life Sciences, Engineering, or related field.
• Manager level: 6+ years of logistics, distribution, or supply chain experience in pharmaceuticals or biotech.
• Sr. Manager level: 8+ years of logistics, distribution, or supply chain experience in pharmaceuticals or biotech.
• Strong understanding of GDP/GxP requirements, biologics handling, and commercial distribution.
• Hands-on experience with serialization and DSCSA compliance (EPCIS, aggregation, product identifier management).
• Experience working with ERP systems (e.g., NetSuite, SAP, Oracle) for order management, inventory, and distribution processes.
• Experience managing 3PL vendors and commercial distribution centers.
• Strong communication, analytical, and cross-functional collaboration skills.

Preferred Qualifications

• Experience supporting commercial product launches in pharma/biotech.
• Knowledge of cell therapy, gene therapy, or advanced biologics distribution.
• Experience with ERP/WMS systems (e.g., NetSuite, SAP, Oracle), serialization platforms, and EPCIS data tools.
• ASCM certified / CLTD (Certified in Logistics, Transportation and Distribution) or related field preferred; equivalent experience considered.
• Strong knowledge of domestic and international shipping regulations (DOT, IATA).
• Project management certification or experience leading cross-functional initiatives.
• Understanding of import/export regulations, customs processes, and global cold-chain requirements.

Competency Definitions

• Strong problem-solving and decision-making ability.
• Vendor management and negotiation skills.
• Ability to work in a fast-paced, rapidly scaling environment.
• Exceptional attention to detail and documentation discipline.
• Ability to influence without authority across cross-functional teams.

Working Conditions

• Office and warehouse environment.
• Occasional travel to 3PLs, packaging vendors, manufacturing sites, or logistics providers.

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.