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Responsibilities:• Provide necessary support to Rx External Manufacturing production at various CMO sites• Qualification of primary and secondary/tertiary packaging systems. Execute testing as needed to support development and submission activities: USP testing; extractables & leachable; shipping tests; child resistance; line and component validation. Provide critical inputs and requirements for product stability and FDA and other agency submissions. Author, review, and coordinate approvals for documentation to support all activities as needed• Provide packaging structural engineering, development and design support• Coordinate structural and artwork development process with graphic designers for new SKU development, commercial launches, and manage routine artwork changes• Initiate and execute primary and secondary package design projects• Maintain packaging database. Create and edit as needed packaging documentation including pBOM and specifications. Develop dielines for artwork working with the manufacturing facilities• Initiate change control for packaging related changes at CMO. Review and approve packaging documentation as needed to support CMO activities• Manage projects related to new product launch packaging activities, facilities and manufacturing changes• Manage suppliers and co-packers. Provide packaging oversight for activities and troubleshoot as necessary for startup, new product or SKU launches and support on-going production
Qualifications / Skills:• BS degree in Engineering (Packaging preferred, Mechanical, Materials Science)• 4-10 years of experience in regulated industry (pharmaceutical or consumer products packaging with Rx packaging preferred)• The candidate should have experience with variety of packaging on both primary (bottles, closures, blisters, pouches) and secondary/tertiary packaging (cartons, labels, shippers, displays). Device or combination product experience a plus• Experience with cGMP’s, all applicable FDA guidelines and Quality Systems. Experience with PPPA/CPSIA regulations and compliance. Prefer additional understanding of ISO, USP, ISTA, ASTM standards• Comfortable working in a team environment with tight deadlines• Experience in packaging operations is desired• Excellent communication, technical writing, and presentation skills• Domestic travel may be required: up to 20% - 30%