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Director, R&D Logistics and Distribution Operations

AstraZeneca
Full-time
On-site
Gaithersburg, MD
$135,200 - $202,800 USD yearly
Operations

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Role Summary

Director, R&D Logistics and Distribution Operations leads end-to-end warehousing, shipping, and receiving for GMP and non-GMP materials at a Pharmaceutical R&D facility, including global import/export operations. Oversees compliant and timebound movement of materials, temperature-controlled shipments, and disposals, adhering to GMP regulations, SOPs, and corporate standards. Manages internal and outsourced staff and supports site-wide colleagues, with focus on continuous improvement and innovation in logistics and warehousing operations.

Responsibilities

  • GMP/Non-GMP Shipping & Receiving: Manage inbound/outbound shipments, inter-site and international shipping, ensuring regulatory documentation and import/export compliance.
  • Compliance: Ensure temperature-controlled GMP shipments with validated cold-chain packaging and monitoring; maintain GDP, GMP, licensing, permitting, and SOP compliance.
  • Timeliness: Ensure timely delivery of critical raw materials for manufacturing and R&D.
  • Collaboration: Coordinate with internal customers, vendors, and carriers for compliant delivery.
  • Inventory, Logistics & Warehousing: Oversee logistics for the R&D Facility and BioCentre, and storage of capital equipment and FF&E onsite and offsite.
  • Process Control: Develop and enforce SOPs for shipping, receiving, disposal, and pest prevention.
  • Continuous Improvement: Lead initiatives to improve cycle time, compliance, and service levels.
  • Inspection Readiness: Ensure areas comply with safety protocols and global trade guidelines.
  • Records Management: Track all shipments, deliveries, and material disposition.
  • Audit Representation: Serve as point of contact during internal audits and external inspections.

Qualifications

Education & Experience

  • Bachelor’s in Supply Chain, Logistics, Business Administration, Life Sciences, or related field; advanced degree preferred.
  • 8–10 years in logistics/supply chain management, with at least 5 years in a GMP-regulated leadership role.
  • Strong understanding of GDP, GMP, FDA, international shipping regulations; experience with cold-chain and temperature monitoring systems.

Skills & Competencies

  • Influence & Stakeholder Management
  • Autonomy & Problem Solving
  • Business Impact
  • Financial Acumen
  • Team Building & Communication
  • Technical Expertise: ERP systems, shipping software, Microsoft Office

Physical Requirements

  • Ability to occasionally lift up to 50 lbs
  • Work in warehouse, shipping/receiving, and office environments
  • Occasional travel for vendor and regulatory meetings

Education

  • Bachelor’s in Supply Chain, Logistics, Business Administration, Life Sciences, or related field; advanced degree preferred.

Additional Requirements

  • Training & Certifications: DOT, IATA, OSHA, HazMat requirements compliant for staff and service providers.
  • Permitting & Licensing: Licenses and permits in GMP/non-GMP and import/export categories as applicable.
  • Pest Control Program: Oversight of pest control to meet GMP and corporate requirements; documentation and corrective actions for regulatory audits.
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