Associate Director, Packaging Engineering – External Manufacturing

This role serves as an essential part of the External Manufacturing & Network Equipment team, overseeing product and technology transfers to Contract Manufacturing Organizations (CMOs). The role involves leading technical interactions with external packaging partners, which are Contract Manufacturing Organizations in the ExM space.

Requirements

• Leading and implementing technology transfers, qualifications, validations, process enhancements, and change controls for projects involving Small and Large Molecule and medical devices and combination products.
• Assurance of compliant packaging and assembly process transfer, site readiness and execution excellence.
• Operating autonomously to offer strong coordination, communication, and supervision on all technical issues related to the responsible external packaging partners.
• Offering technical expertise in quality and supply investigations with external packaging partners.
• Leading discussions on packaging processes, equipment, and components to help identify root causes and develop effective corrective and preventive actions.
• Conducting all technical evaluations of external packaging partners and creating comprehensive technical assessments during the final selection phase.
• Participating in periodic Business Review Meetings with external packaging partners.
• Leading complex changes of packaging images and primary, secondary, and tertiary materials/components.
• Overseeing the qualification of relevant modifications to distribution and thermal transport/storage methods for finished packaging configurations.
• Offering technical guidance to support the commercial agreements between ExM and the external packaging partner.

Benefits

• Flexible work arrangements
• Hybrid work schedule