Oversee and execute global import and export activities in compliance with applicable trade regulations, including management of licenses, permits, and country-specific requirements.
Act as Importer of Record (IoR) when required, ensuring full compliance with statutory obligations and recordkeeping requirements.
Ensure internal procedures and broker practices remain aligned with evolving regulatory requirements.
Prepare, review, and maintain shipping documentation, ensuring inspection-ready archiving and recordkeeping.
Manage domestic and international logistics for cell banks, drug substance (DS), drug product (DP), and devices, ensuring timely and compliant delivery across the global clinical supply network.
Ensure real-time shipment visibility and timely resolution of logistics deviations, including delays, temperature excursions, and customs issues.
Establish, qualify, and maintain compliant logistics lanes, shipment models, and escalation pathways.
Build and manage a network of freight forwarders, couriers, and customs brokers, including sourcing, evaluation, selection, onboarding, and performance management.
Oversee GMP and Non-GMP inventory management, including tracking, reconciliation, and control across CMOs, depots, laboratories or other required sites.
Establish and oversee periodic inventory verification and review activities to ensure inventory accuracy, compliance and destruction as appropriate.
Investigate and resolve inventory discrepancies in partnership with Quality, CMOs, and internal partners.
Ensure logistics and inventory activities comply with GMP, GDP, GxP, and internal SOPs; support audits and regulatory inspections.
Partner with Quality on deviation investigations, root cause analysis, and CAPA implementation related to logistics, inventory, or trade compliance.
Perform Clinical Supply Chain activities, such as, but not limited to, study level forecasting and planning, packaging and labeling and/or finished goods distribution.
Develop and maintain SOPs, work instructions and reporting to support operational excellence and scalability.
Maintain Supply Chain Management metrics and KPIs to support internal reporting and external reporting for vendor oversight/governance

Requirements

S/M.S. Science or Engineering, or related fields with 5+ years of relevant experience in clinical supply chain logistics and inventory management
Hands-on experience with international import/export controls and trade compliance
Experience acting as Importer of Record (IoR) required
Licensed Customs Broker (LCB) certification strongly preferred
VAT recovery and tariff knowledge is preferred
Demonstrated experience managing GMP and Non-GMP materials and temperature-controlled supply chains
Experience with ERP, IRT, Forecasting tools or inventory management systems
Working knowledge of the International Conference on Harmonization (ICH) guidelines, the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines, and a solid understanding of Good Manufacturing Practices (GMP)
Proven ability to manage multiple projects, proactively identify and resolve issues using strong attention to detail and problem-solving skills
Ability to adapt to a fast-paced, dynamic work environment and navigate through ambiguity
Excellent communication and influencing skills, strong collaboration skills
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Strong knowledge of Microsoft Office, including Excel, Word and PowerPoint
Smartsheet experience is strongly preferred. PowerBI, experienced excel (macros) and/or Tableau is a plus
Position requires up to 25% travel (domestic and international) including mandatory in-person attendance at All Hands meetings typically held twice per year

Benefits

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical supply chain logisticsinventory managementimport/export controlstrade complianceGMP materials managementtemperature-controlled supply chainsproject managementproblem-solvingforecastingrecordkeeping

Soft skills

attention to detailadaptabilitycommunicationcollaborationinfluencingproactive issue resolutionnavigating ambiguityoperational excellencescalabilityteam management

Certifications

Licensed Customs Broker (LCB)