OverviewJob SummaryWe are seeking an experienced Sr. Logistics Specialist with a strong background in import/export compliance to lead and manage domestic and international logistics operations in the life sciences industry. This role will oversee the end-to-end movement of highly regulated products domestically and across global borders while ensuring full compliance with U.S. and international trade, customs, and regulatory requirements, including those from FDA, CBP, IATA, and other global authorities.
The ideal candidate will combine strategic logistics oversight with deep regulatory knowledge to build scalable processes, mitigate risk, and enable uninterrupted movement of life sciences products including biological materials, medical devices, reagents, and pharmaceuticals.
ResponsibilitiesKey Accountabilities- Lead development and implementation of a comprehensive domestic and international trade compliance framework inclusive of SOP's, Work Instructions, and strategies aligned with global regulations and company objectives.
- Ensure end-to-end compliance with U.S. and international import/export regulations, including EAR, ITAR, FDA, CBP, USDA-APHIS, and OFAC requirements.
- Implement and maintain a centralized Product Database for all imported/exported SKUs, classifying products using HTS codes and ECCNs, documenting Country of Origin, Manufacturer Registration ID's, etc. to ensure accurate documentation, declarations, and shipment routing.
- Coordinate global shipments of life sciences products, including temperature-sensitive, hazardous, and biologically restricted materials, with appropriate cold-chain logistics.
- Manage relationships with customs brokers, freight forwarders, couriers, carriers, and third-party logistics providers while conducting regular business reviews and developing, implementing, and monitoring KPIs to drive performance, ensure compliance, and support timely shipment execution.
- Manage the transportation service provider network, including continuous improvement in supplier evaluation, qualification, onboarding, and performance management mechanisms while conducting business reviews and implementing/monitoring KPIs to drive performance, ensure compliance, and support timely shipment execution.
- Resolve domestic and international shipping issues proactively, coordinating with logistics partners and internal stakeholders to minimize delays and regulatory risk.
- Prepare, review, and maintain import/export documentation, including commercial invoices, packing lists, certificates of origin, shipping declarations, and internal shipment records.
- Partner with Regulatory Affairs, Quality, Legal, R&D, and other stakeholders to align logistics operations with regulatory and product-specific requirements.
- Monitor regulatory changes, assess business impact, develop SOPs, Work Instructions, and training programs, and facilitate internal/external audits - including CBP Focused Assessments and FDA logistics inspections - while implementing corrective actions.
- Plan and provide input for inbound/outbound freight and packaging budgets, identify cost-saving opportunities, and prepare compliance and logistics reports for audits and internal reviews.
- Performs other duties and responsibilities as assigned
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Networking/Key relationshipsSuppliers, Executive Management, Sales, Marketing, Customer Service, Corportate Supply Chain, Distribution, Finance, Logistics, R&D, and Plant Operations/Manufacturing, QA/RA
QualificationsMinimum Knowledge & Experience required for the position:- Bachelor's degree in Supply Chain Management, International Business, Logistics, or related field-or equivalent professional experience.
- 5-7 years of experience in Pharma or Biologics industry specifically in Procurement, Supply Chain, and/or Manufacturing in a regulated environment.
- Strong understanding of import/export regulations (e.g., U.S. EAR, ITAR, EU regulations, Incoterms, customs valuation, documentation).
- Experience working with freight forwarders, customs brokers, and international carriers.
- Excellent organizational, analytical, and communication skills.
- Professional certifications (e.g., CUSECO, CCS, CES, CLTD or equivalent) preferred.
- Experience working with products controlled by shelf life
- Experience with using ERP systems and/or TMS applications; Preferably SAP.
Skills & Capabilities:- Highly skilled in import/export compliance
- Strong transportation service provider relationship builder and performance driver.
- Strong verbal and written communication skills, strong negotiation acumen
- Works well with diverse groups of people, strong interpersonal skills
- High level of autonomy
- Proficient with Statistics
- Advanced Microsoft Offics skills (Excel, PowerPoint, Word, Outlook)
Travel requirements:- Up to 10% of time, to include international travel
