Associate Director, Packaging Engineering – External Manufacturing

Job Description

Job Description:

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. You will work closely with other ExM functions (Quality, Operations, Supply Chain, Procurement) and technology experts within the Centers of Excellence. The engineer will leverage their scientific, technical, and business expertise to lead teams in solving complex packaging issues, optimizing processes, and ensuring compliance, focusing on developing and executing primary and secondary packaging components for Small and Large Molecule assets, assembling Medical Device Combination Products, designing packaging equipment, and ensuring packaging process control and efficiency.  Effective collaboration with teams is crucial to achieving the companies goals. The position requires advanced skills in creating and improving business, technical, and compliance processes, and leading high-impact cross-functional teams.

Essential Duties and Responsibilities:

• Tasked with 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.

• Offer technical expertise in quality and supply investigations with external packaging partners.  Lead discussions on packaging processes, equipment, and components to help identify root causes and develop effective corrective and preventive actions.

• As a member of the ExM Packaging Focus Factory team (Operations, Quality, Technology), establishing a calibrated technical oversight approach based on the product type, as well as the capabilities and technical competence of an external partner to drive scientific rigor and execution excellence. 

• As part of the ExM Focus Factory team, setting clear expectations, establishing metrics, and regularly monitoring both operational and quality performance related to external packaging partners.

• Conduct all technical evaluations of external packaging partners and create 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.

• Oversee the qualification of relevant modifications to distribution and thermal transport/storage methods for finished packaging configurations.

• Offer technical guidance to support the commercial agreements between ExM and the external packaging partner.     

Required Experience and Qualifications:

• Minimum of 10 years’ experience in the medical device or combination product engineering and pharmaceutical field, with extensive practical knowledge in supporting packaging operations, managing packaging materials and components, and overseeing packaging processes.

• Strong preference for candidates with leadership experience at a pharmaceutical packaging facility or an External Manufacturing site.

• Extensive experience in handling Capital packaging equipment projects, including technology transfers, designing packaging lines, creating purchase specifications, managing equipment installation and validation, pursuing operational excellence, and troubleshooting on the shop floor.

• Broad experience with devices and combination products, covering design control to product and technology transfer for both new and existing packaging facilities.

• Exceptional project management skills, from conception and initiation, through project close-out.