Senior Manager, Clinical Supply Chain

Revolution Medicines•Redwood City, CA

2d•$164,000 - $205,000•Onsite

About The Position

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. The Opportunity: Commercial Supplies Packaging Management. 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.

Requirements

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 and Supply Chain teams.
Effective, open, and transparent communication skills (verbal and written).
Capable of working on multiple projects/tasks and able to meet timelines.
Self-starter with a high level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results.
A team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.

Nice To Haves

Familiarity with pharmaceutical serialization requirements, including DSCSA and EU Falsified Medicines Directive (FMD).

Responsibilities

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.