Manager, Logistics - MGI PHARMA - Baltimore, MD

Manager, Logistics - MGI PHARMA - Bloomington, MN

Position Overview

This individual ensures the efficient flow of materials and product through the product supply system by coordinating the planning and scheduling of materials and products through the production cycle. Determines appropriate inventory levels and ensures inventory monitoring and control systems are in place and in use. Coordinates both internal and external manufacturing of commercial product and samples (including Drug Substance, as required). Works closely with Technical Operations, Corporate Quality, Regulatory Affairs, Finance, and other internal and external organizations.

Critical Performance Areas

1. Planning and Analysis – Plans and schedules production and product/material flow for commercial products, both domestic and international. Determines production schedule for Baltimore Manufacturing and also for external vendors.
2. Materials Management – Procures and maintains appropriate inventory levels and records. Processes and documentation comply with GMPs, corporate policies, and Sarbanes-Oxley requirements.
3. Internal/External Interfaces – coordinates Product Supply activities with various organizations within MGI and also with vendors and contractors (both domestic and international). Able to quickly identify and resolve issues.

Essential Job Functions

· Production planning/forecasting of Manufacturing for commercial product (Drug Substance, Drug Product, and samples)
· Scheduling of Manufacturing runs (both in-house and contracted)
· Procurement, ordering, inventory management, and safety stock levels of API, components/raw materials, WIP, and finished goods
· Procurement, ordering, inventory management, and safety stock levels of printed materials. Responsible for actual disbursement of release labeling at Baltimore site.
· Coordination of Printed material sourcing
o primary contact with vendors
o secure labeling proofs for Regulatory’s use in submissions
o labeling procurement and change control post-approval (with QA/RA)
· Coordination of delivery of Drug Substance and Drug Product with Distribution function in order to meet all customer due dates and avoid backorders
· Ownership and compliance of GMP inventory control system
· Ownership and compliance of GMP purchasing system
· Coordination of the destruction of raw materials, Drug substance, WIP and/or Drug Product per procedures
· Compilation of monthly inventory information to Finance
· Coordination of physical inventory audits with Finance, as required
REQUIREMENTS
· BS/BA in Industrial Engineering, Operations Research, Business or related field
· At least 10 years’ related experience in Production Planning and/or Materials Management
· Previous experience in the pharmaceutical or other FDA-regulated industry desirable

Other Skills/Abilities

· APICS Certification (CIPM and/or CIRM) is desired
· Demonstrated proficiency at problem-solving and successfully managing multiple priorities
· Strong interpersonal communication skills – both written and verbal
· Able to work effectively as part of a team, able to perform their duties with minimal supervision, and able to recommend direction and actions across organizational boundaries

NOTE: This job description is not intended to be all-inclusive. Associate may perform other duties to meet the ongoing needs of the organization.

AN EQUAL OPPORTUNITY EMPLOYER