The Position
Reporting to the Associate Director, Clinical Supplies & Logistics, the Manager/Sr. Manager, Logistics Contractor, will be responsible for providing global logistical support for the end-to-end supply chain for gene editing programs, coordinating movement of raw materials, drug substance, drug product, and equipment in support of manufacturing and supply activities at external vendors across various geographies. The candidate must have significant technical experience related to logistics management practices in the pharma/biotech space, with a strong understanding of GxP concepts, cold chain shipping, and global trade regulations related to the import and export of materials across customs borders. The ideal candidate will show ownership of all shipping activities and confidently speak to the logistics function to internal and external stakeholders.
Job Responsibilities
- Manage global cold chain logistics:
- Coordinate shipments of GMP and non-GMP bulk and sample material between storage sites, CDMOs, internally, and CLOs.
- Classify internal materials for customs and generate necessary customs documentation when needed (e.g. invoices, USDA statements, end use letters etc.).
- Manage relationships with third party logistics partners and customs brokers.
- Coordinate shipping activities with Quality Assurance to ensure material is transferred in a manner compliant with internal procedures and industry regulations; initiate deviations and CAPAs related to product shipping as required.
- Assess shipping systems for suitability for packout and transport of clinical phase production materials.
- Internal logistics infrastructure:
- Support implementation of internal ERP inventory management system.
- Represent Technical Operations as the SME for Logistics related to change controls, technology transfers, new vendor introductions, and ad-hoc cross-functional projects.
- Coordinate with internal and external stakeholders on shipping process to proactively implement process improvements to reduce risk and costs and drive efficiencies within supply chain.
- Business support:
- Contract and budget support for logistics service providers and consultants
- Track and coordinate VAT and customs duties spend and reclaims with external vendors.
Qualifications
- Bachelor's degree in a business, scientific, or related field
- 5+ years of experience in a biotechnology or pharmaceutical company (position level dependent on candidate experience)
- Experience interfacing with external contract manufacturing organizations.
- Experience in international and domestic cold chain logistics, specifically within the BioPharma industry. Preference for candidates with experience managing shipment of frozen materials.
- Working knowledge of global customs procedures, including ability to independently research and assign global harmonization codes and an understanding of VAT exposure and reclaim procedures.
- Strong organizational and interpersonal skills with ability to manage activities supporting many different stakeholders, both internal and external.
- Excellent communication skills, with an emphasis on clear, accurate, and detailed verbal and written correspondence.
- Demonstrated ability to competently author GxP compliant documents and reports such as shipping forms, deviations, investigations, and CAPAs is required.
- Knowledge of gene or cell therapy supply chain preferred.
- Experience with commercial shipping validation preferred but not required.