Mirrai Careers

Manager, Drug Product, Packaging

Revolution Medicines

Redwood City, California, United States Full-time Posted 13d ago
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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 RAS. Founded 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 rigor—all 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: * 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. #LI-CT1 #LI-Hybrid  The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected]. Base Pay Salary Range $143,000—$178,000 USD ---------------------------------------- We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.   Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.   If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness. ----------------------------------------

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