Job Details

Target PR Range: 65-75/hr DOE

Position Summary     

Position performs activities related to Global Logistics and inventory management to support customer and manufacturing sites in cooperation with internal and external partners.  The role requires an understanding of GXP, planning/scheduling, inventory management, clinical and commercial logistics, cold chain, import/export, and global trade compliance. The individual will be responsible for logistics for international bulk material movements, all phases of clinical studies, expanded access/named patient programs and commercial supply for the company. The candidate has a demonstrated ability to work independently and expediently to obtain tangible results.

Responsibilities

·       Create/Support shipments for bulk drug substance, drug product, finished goods, intermediates and sample shipments to global sites.

·       Manage and execute shipping forecast with Clinical/Commercial Operations.

·       Create shipment documents, e.g. Commercial Invoices for import or export, End Use Letters, USDA Letters, import applications and permits.

·       Create Distribution Protocols for third party Contract Manufacturing Organizations (CMOs) and 3PL Distribution Centers

·       Create SOPs / COPs for approved freight carriers

·       Maintain shipment database to record and track all shipments and record keeping of shipment documentation, communications, and temperature results.

·       Manage Deviations due to temperature excursions or shipment discrepancies in Veeva QMS

·       Veeva QMS document control, SOP creation, Deviation, CAPAs, Change Actions and Change Controls

·       Execute appropriate inventory movement transactions within the ERP system.

·       Perform inventory reporting and reconciliation monthly, or as required.

·       Provide internal customer service for shipment requestors across all offices and programs.

·       Create and maintain relationships with approved carriers, 3PLs, and CMOs.

·       Assist Finance with inventory reconciliation and financial close.

·       Track all shipment issues (damage, temperature excursions, non-compliance, etc.) and work to resolve recurring problems with permanent solutions.

·       Enforce consistency and compliance with Global Logistics policies, procedures and applicable regulatory authority directives and regulations.

·       Follow the procedures and requirements associated with Global Trade Compliance.

Requirements

·      Bachelor’s Degree required

·      3-5 years in a Supply chain or Pharma / Biotech Cold Chain Logistics environment.

·      Working knowledge of GMP, GDP, pharmaceutical industry procedures and regulations.

·      Familiarity with SOPs, SOW, COPs and Distribution Protocols

·      Experience with Quality Management systems (Veeva experience a plus).

·      Flexibility and the ability to manage change.

·      Excellent written and verbal communication skills.

·      Well-developed interpersonal skills and the ability to work well as part of a team.

·      Solid organizational, time management and project management skills.

·      Strong interest in Supply Chain and Logistics

*CO/NYC candidates might not be considered