The Opportunity:

Lead and oversee packaging technical transfers, packaging-line and equipment qualification activities, and packaging lifecycle management for assigned commercial products and CMO sites. This includes transfer planning and execution; packaging process, component, equipment, and line-readiness assessments; qualification and validation strategy; ongoing performance monitoring; and implementation of post-approval packaging changes, process improvements, and supply-continuity initiatives throughout the product lifecycle.

The successful candidate will serve as the primary packaging technical person for assigned CMOs, partnering cross-functionally with Quality, Supply Chain, Regulatory, Manufacturing, and external partners to manage packaging performance, investigate issues, drive continuous improvement, and maintain a state of inspection readiness.

• Serve as the primary technical person for assigned commercial CMOs, providing day-to-day oversight of packaging operations, technical performance, and compliance.

• Assess CMO packaging-site capability, capacity, infrastructure, and readiness to support commercial demand and future product needs.

• Evaluate and define requirements for primary packaging components, packaging lines, inspection systems, serialization, automation, and other site-specific equipment.

• Manage packaging technical transfers, including transfer planning, site and line readiness, process implementation, execution support, and post-transfer monitoring.

• Manage packaging equipment and process qualification, validation, PPQ, and continued process verification (CPV) activities.

• Manage packaging lifecycle activities, including post-approval changes, component or equipment changes, line improvements, process optimization, and supply-continuity initiatives.

• Manage packaging-related deviations, complaints, nonconformances, investigations, root-cause analyses, CAPAs, and change controls.

• Partner with Quality, Supply Chain, Regulatory, and CMO teams to maintain cGMP compliance, drive continuous improvement, manage documentation, and prepare for audits and inspections.

• Support APQRs by authoring appropriate packaging sections.

Required Experience, Skills and Education:

• Bachelor’s or master’s degree in Packaging Engineering, Packaging Science, or a closely related engineering discipline.

• Approximately 6–8 years of relevant pharmaceutical, biotechnology, medical device, or similarly regulated industry experience.

• Demonstrated commercial packaging experience, including responsibility for packaging operations, packaging engineering, or technical support.

• Experience managing or providing technical oversight to external CMOs, contract packagers, or commercial packaging sites.

• Strong knowledge of primary packaging systems, packaging equipment, line qualification, validation, PPQ, and Continuous Process Verification (CPV).

• Working knowledge of cGMP requirements and quality systems, including deviations, CAPA, complaints, change control, and technical documentation.

• Demonstrated ability to assess packaging-site capability, capacity, equipment needs, and operational risks.

• Strong communication, technical writing, project-management, and cross-functional collaboration skills; willingness to travel to CMO sites as needed.

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