Manager, Drug Product, Packaging
Revolution Medicines
Summary
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.
Job description
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.
Requirements
- 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.
Benefits
- Equity awards
- Competitive cash compensation
- Learning and development opportunities
Company overview
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The company is pioneering a new class of therapeutics that target oncogenic RAS mutations, which are among the most common drivers of human cancers. Revolution Medicines employs a unique approach to drug discovery, leveraging deep insights into RAS biology to develop small molecule inhibitors that can address previously undruggable targets. Their pipeline includes multiple clinical-stage candidates designed to inhibit various RAS pathway mutations, with a particular focus on KRAS G12C and other RAS variants. The company's scientific platform combines structural biology, medicinal chemistry, and computational approaches to design highly selective inhibitors. Revolution Medicines aims to transform cancer treatment by developing therapies that can overcome resistance mechanisms and provide durable clinical benefits for patients with RAS-driven malignancies. Their research represents a significant advancement in the field of targeted cancer therapy, addressing one of the most challenging areas in oncology drug development.