Astellas Pharma Associate Manager Package Engineering in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing an Associate Manager Package Engineering opportunity in Northbrook, IL.
Purpose & Scope:
The Associate Manager, Package Engineering is responsible for implementing Astellas' packaging objectives, by applying advanced principles of package engineering to execute technical designs and development of product packaging for use throughout the entire supply chain.
Essential Job Responsibilities:
Apply advanced package engineering principles to create fit-for-purpose packaging for commercial products.
Oversee shipping or simulated shipping tests, as required, to meet quality specifications. Ensures that the package and standard shipping unit (shipper, pallet, etc.) will hold up throughout the entire supply chain.
Create and maintain package component Technical Drawings and specifications, as needed.
Responsible for reviewing test protocols, for OQ, PQ & PV package tests in CMO packaging facilities.
Manages package engineering activities through others, i.e. contract manufacturers, consultants, third-party logistics providers, testing labs, etc. with oversight from direct line manager
Implement continuous improvement projects for packaging, and packaging line issues as they develop.
Provide support for developing packaging configurations for CTM and new products.
Support CTD documentation.
Support Corrective Action Preventative Action (CAPA) documentation, perform Root Cause Analysis (RCA), Failure Mode and Effect Analysis, (FMEA), and implement corrective Action (CA) on identified issues, as needed.
Develops strong relationships with key internal and external partner organizations including, but not limited to: component suppliers, contract packers, third party logistics, product strategy leads, Quality Assurance, Procurement, Business Development, Research and Brand teams.
Up to 10% travel, domestic and international, may be required.
This position may work as part of a product launch team, which directly impacts the following:
Cost of Goods
Product Launch Timelines
This position reports to the Associate Director of Package Engineering.
Packaging Engineering resides within Pharmaceutical Research Technology Labs (PRTL).
Bachelor's degree in Package Engineering, Mechanical Engineering or Chemical Engineering.
In situations where precedent may not exist, is able to independently exercise judgment, determine appropriate solution, and take action.
Must have five to seven years' experience, with increasing responsibilities, in Package Engineering or related field.
Demonstrated project management and leadership skills.
Demonstrates knowledge of industry best practices and trends.
Must have excellent analytical, problem-solving and communication skills to deal with all levels of the organization.
Master's degree in technical or business is preferred.
Pharmaceutical GMP & GDP experience is a plus
Device engineering experience is a plus
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Supply Chain