Duties and Responsibilities:
• Responsible for planning and implementing activities related to the material purchase, material control, inventory control, and shipping/receiving and stores functions.
• Develops, implements and maintains policies, procedures and material control systems, ensuring materials are ordered and in stock to meet company requirements while maintaining acceptable inventory levels.
• Coordinates production plans to ensure materials are provided according to schedules to maintain production, interfacing with Customer Service, Sales, Production, Quality Control, Clinical Research and corporate partners.
• Ensures materials are received from proper vendors, delivered to inventory, packaged according to specification and shipped in a timely manner.
• Ensures the security and accountability of materials and goods in the warehouse.
• Maintains inventory records for raw materials, packaging components, intermediates and finished goods, through manual or automated systems.
• Operate within cGMP guidelines, government agency regulations (e.g., EPA, OSHA, DEA, FDA) and company’s Standard Operating Procedures.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as advisor to other team members to meet schedules and/or resolve technical problems.
• Requires a Bachelor’s degree or equivalent experience.
• Requires 5 to 8 years experience in materials management and/or planning in GMP regulated pharmaceuticals manufacturing environment.
Technical Skills Required:
• Demonstrated leadership in developing drug product materials management processes
• Proven track record developing and implementing robust and efficient ERP/MRP systems
• Certification by the American Production and Inventory Control Society highly desirable.
• Broad understanding of SCOR & APCIS model for effective materials management
• Radiopharmaceuticals experience would be desirable.
• Extensive experience in collaborating with sites and third party manufacturers
• Experience in troubleshooting and general Materials review board support (documentation reviews, deviation investigations, etc.) for drug product
• Experience in cGMP manufacturing for late Phase, CMC, drug product launch activities