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.