Manager/Senior Manager, Shipping and Logistics (Research & Development)

Reports to: Vice President, Program & Portfolio Management, Research & Development

Location: Remote Work (US Only)

Position Summary: 

The Manager/Senior Manager, Shipping and Logistics, Research & Development will lead global logistical operations, ensuring compliance with regulations and efficient planning and coordination of shipments and material inventory in support of our vaccine development programs. The ideal candidate will have expertise in export/import classifications, trade control, shipping logistics, and project management with a focus on supporting the movement of clinical and commercial pharmaceutical materials. This role requires strong communication and organizational skills and a proactive approach to problem-solving.   

Responsibilities:

Management of Shipping Logistics

• Lead global sample and investigational vaccine product logistics operations aligned with Good Distribution Practices (GDP) to ensure timely delivery adherent to regulatory requirements and appropriate quality standards, including on-time delivery within predetermined parameters such as controlled temperature.
• Arrange and track global shipments of pre-clinical and clinical samples, drug substance (DS), drug product (DP), in-process and final samples, and other materials, mitigating risks to ensure on-time delivery.
• Maintain strong relationships and collaborate effectively with all third-party vendors to ensure smooth operations and compliance. 
• Identify risks associated with international shipping and logistics; develop and implement mitigation strategies to minimize disruptions.
• Proactively address challenges related to international transport of biological, including infectious samples, customs clearance, transportation delays, and regulatory approvals.
• Work closely with cross-functional teams, external partners, and regulatory bodies to define and streamline logistics processes and resolve any potential issues.
• Maintain adherence to terms of Supply Agreements and Quality Agreements.

Compliance

• Lead export and import classifications for investigational vaccine products, clinical samples and materials ensuring compliance with all relevant trade regulations.
• Oversee license applications, agreements, and registrations in support of trade controls under International Traffic in Arms Regulations (ITAR, 22 CFR), and Export Administration Regulations (EAR, 15 CFR).
• Collaborate with Government agencies, Ministries of Health, and partners to secure necessary approvals in a timely manner, maintaining strict adherence to trade control regulations.
• Ensure compliance with CDC, USDA, FDA, and other global permits and practices such as GDP, as required for the shipment of biological materials.
• Build and maintain policies, procedures, and training which ensures best practices and compliance with regulations. 

Coordination With Contract Manufacturing and Analytical Vendors

• Partner and engage with vendors to ensure manufacturing/production planning and testing availability is secured and aligns with Project Plans.
• Manage tracking and coordination of investigational vaccine product and materials such that production and testing readiness is unconstrained, and future planning is proactive.

Project Management 

• Manage inventory tracking systems for all project related vaccine materials, including clinical/non-clinical samples, drug substance, drug product, analytical testing, and stability samples to ensure both visibility and effective planning. 
• Lead projects of moderate scope and complexity in support of vaccine development and R&D Operations. 
• Work collaboratively with consultants/contractor/partner project managers as needed to ensure timely project execution.
• Work with finance and program staff to manage budgets and estimate actuals and accruals for projected spend.
• Identify potential internal and external risks and possible impact to strategies and plans.
• Partner with Sabin colleagues to manage objectives to achieve key milestones within time, budget and quality parameters; apply technical and operational knowledge.

• Bachelor’s degree in a related field, experience in pharmaceutical industry required
• 7+ years relevant experience in global shipping, logistics, import/export, and trade control of investigational vaccine product, samples, and materials within and between countries 
• Experience building or maintaining trade compliance programs
• Understanding and experience with Good Distribution Practices for pharmaceuticals
• Demonstrated skills in developing and managing plans and budgets, with multiple partners and vendors 
• Experience in Project Management and use of MS Project, Smartsheet, and/or other project management tools is desired
• Demonstrated proficiency in core Microsoft 365 applications
• Ability to work across the organization and build strong relationships with colleagues, managing their expectations
• Strong communication and interpersonal skills; ability to be flexible and optimistic
• Strong attention to detail, ability to manage complex tasks, highly organized, dependable and able to prioritize competing demands to meet deadlines
• Ability to process information quickly and listen carefully to feedback and comments from staff and adapt plans/actions accordingly
• Commitment to furthering Sabin’s mission
• Ability to travel domestically and internationally with notice

Sabin’s philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the starting annual salary for this position ranges from $95,000 - $132,000. The exact compensation may vary based on skills, experience, training, certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs. 

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.