Manager, Drug Product, Packaging

Revolution Medicines is a global commercial-state oncology company dedicated to discovering developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform the company is advancing a broad integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active cancer-driving state of on rigorous scientific inquiry and a willingness to challenge long-held assumptions Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science challenge assumptions act with urgency and hold ourselves to a high standard of rigorall in service of patients.

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:

• Bachelors or masters degree in Packaging Engineering Packaging Science or a closely related engineering discipline.

• Approximately 68 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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