Manager / Senior Manager, Commercial Logistics

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.