Job Description

Role Summary:

OmniaBio is seeking a dynamic and forward-thinking Director of Logistics to lead the global movement of critical materials and products across our advanced Cell and Gene Therapy (CGT) manufacturing network. This role is pivotal in ensuring the reliable, compliant, and efficient transportation of high-volume raw materials, consumables, samples, drug substances, and drug products across Canada, the United States, Europe, Asia, and other global regions. The successful candidate will bring deep expertise in cross-border logistics, GMP-compliant supply chain operations, and regulatory frameworks, while also championing the integration of AI, automation, and digital tools to transform logistics into a strategic enabler of manufacturing excellence for high-throughput personalized medicines. This leader will spearhead initiatives to optimize shipping lane selection, enhance cold chain reliability, and orchestrate logistics in alignment with manufacturing execution systems (MES) and enterprise resource planning (ERP/SAP) platforms. Reporting to the Vice President, Supply Chain, the Logistics Director will play a critical role in ensuring that OmniaBio's logistics operations support the timely, safe, and cost-effective delivery of life-saving therapies to patients worldwide.

Key Responsibilities:

Strategic Logistics LeadershipLead global logistics management and strategy for CGT materials and products, ensuring seamless, compliant, and timely movement across international borders. Develop and implement logistics frameworks that support late-phase clinical and commercial manufacturing, with a focus on reliability, speed, and regulatory compliance. Collaborate with Manufacturing, Quality, Regulatory, and Supply Chain teams to align logistics operations with production schedules and client commitments.

AI-Driven Optimization & Digital TransformationLead a cross-functional initiative to optimize shipping lane selection and logistics performance using AI-powered analytics and other AI tools. Integrate logistics workflows with SAP (ERP) and MES platforms to enable real-time orchestration of material flows and manufacturing slot alignment. Champion the use of digital dashboards and data visualization tools to monitor logistics KPIs, identify bottlenecks, and drive continuous improvement.

Compliance & Risk ManagementEnsure full compliance with international trade regulations, including Health Canada, FDA, EMA, and other global regulatory bodies. Own and maintain the Shipping Validation Master Plan, ensuring all logistics processes meet GMP and GDP standards. Develop and implement risk mitigation strategies, including contingency planning for cold chain failures, customs delays, and transportation disruptions.

Operational ExcellenceOversee import/export operations, customs clearance, and documentation for all CGT-related shipments. Lead the selection, qualification, and performance management of couriers, freight forwarders, and third-party logistics providers. Support packaging selection and qualification for GMP cold chain shipments, ensuring product integrity throughout transit.

Serialization, Traceability & DistributionDevelop and implement serialization strategies to ensure traceability and compliance across the distribution of drug substances and drug products. Collaborate with Quality and Regulatory teams to ensure logistics systems support data integrity, audit readiness, and end-to-end visibility.

Qualifications:

Education: Bachelor's degree in Logistics, Supply Chain Management, Business Administration, or a related field. Experience: Minimum of 10 years' experience in logistics, preferably in the pharmaceutical or biotechnology industry with a focus on cross-border operations. Technical Skills: Familiarity with import/export software, ERP systems, and data analysis tools. Knowledge: Strong understanding of Canadian and US customs regulations, as well as industry-specific requirements for cell and gene therapy products. Soft Skills: Excellent organizational, problem-solving, and communication skills; ability to work collaboratively across teams and adapt to a fast-paced environment.

Desired Characteristics:

Strategic thinker with a hands-on approach to execution. Passion for innovation and continuous improvement. Strong analytical mindset with a focus on data-driven decision-making. Customer-centric and quality-focused, with a deep understanding of CGT logistics challenges. Willingness to travel between Canada and the US as required. Ability to work flexible hours to accommodate international operations. * Commitment to maintaining the highest standards of safety and quality in all logistics processes.