Senior Manager, Clinical Supply Chain

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development.

As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

• Serve as the primary technical point of contact for external contract packaging organizations and packaging component suppliers.
• Provide technical support for routine commercial packaging operations at external Contract Manufacturing Organizations (CMOs), including management of deviations, complaints, and investigations related to packaging, labeling, and logistics.
• Drive timely issue resolution to ensure product quality, regulatory compliance, and continuity of supply.
• Partner closely with Quality, Manufacturing, and external partners to ensure uninterrupted commercial supply.
• Support department leadership with resource planning and financial reporting activities.
• Initiate, review and approve internal and CMO specifications for primary, secondary, and tertiary packaging components used for commercial products.
• Author and maintain Bills of Materials (BOMs) and packaging process instructions for new and existing products.
• Collaborate with Technical Development to provide input on manufacturability, scalability, and packaging design for Revolution Medicine products.
• Lead or support technology transfer activities for packaging processes from development to commercial manufacturing.
• Participate in or lead packaging process validation activities for solid dose products across global manufacturing networks.
• Maintain awareness of and ensure compliance with cGMP, regulatory, and internal quality requirements applicable to global pharmaceutical packaging operations.
• Provide all packaging-related support to enable new product launches.
• Support regulatory submissions, inspections, and responses related to packaging and labeling and serialization activities, as needed.
• Ensure all supplies are controlled and distributed in accordance with GMP, GCP, and GDP.
• Develop, maintain and enforce department’s business processes and/or SOPs.
• Identify and implement process improvements to increase efficiency, reduce costs, and minimize waste.

• B.S. or M.S. in, Mechanical or Packaging Engineering, or related field with 8+ years of experience in pharmaceutical logistics and inventory management.
• Strong knowledge of cGMPs, pharmaceutical manufacturing principles, and global packaging standards.
• Technical proficiency, independent thinking, teamwork and collaboration, including driving continuous improvement.
• Demonstrated experience with primary, secondary and tertiary packaging for solid dose products
• Experience supporting new product introductions, technology transfers, and commercial launches in major global markets.
• Proven experience working with and managing external contract packaging organizations.
• Experience managing complex, cross functional projects across multiple regions and time zones.
• Knowledge of distribution and cold chain shipping requirements for pharmaceutical products; experience with shipping qualifications and transportation studies is a plus.
• Financial acumen related to budgeting, forecasting, and cost optimization.
• Working knowledge of statistical methods and software to support packaging process optimization and troubleshooting.
• Working knowledge of pharmaceutical commercial manufacturing, regulatory, and quality assurance.
• Solid project management, facilitation, and problem-solving skills.
• Solid organizational and time management skills.
• Strong communicator and connector between Commercial, Finance, Quality, Regulatory…