The Opportunity:

Responsibilities:

• Responsible for ongoing management of RevMed’s global network of Drug Product Manufacturers.

• Drive implementation of RevMed’s CMO Lifecycle Management Program across our network of Drug Product CMOs. Support identification, selection, on-boarding, start-up and ongoing management of CMO’s. 

• Lead CMO management activities, including business and manufacturing support, issue resolution, and performance management. Lead weekly cross-functional site leadership team meetings with CMO to ensure all start-up and production activities are conducted successfully on-time. 

• Understand CMO partner internal structure and processes and work with team to ensure successful production, issue resolution and communication takes place to meet RevMed’s production requirements.

• Lead site issue management and resolution during routine production and escalate issues, when appropriate. Drive risk management activities, including the identification of risks and creation of mitigation plans.  Support product transfer activities to the CMO.

• Establish and maintain effective relationships with key CMO stakeholders to ensure successful manufacture and issue resolution across the external manufacturing network. Foster collaborative relationships with internal stakeholders (e.g. Clinical Operations, Development, Regulatory, Quality, Operations, Finance, etc.) to understand organizational needs.

• Create and manage contracts, requests for pricing, supply agreements, etc. Ensure activities are executed in alignment with established Supply and Quality Agreements. Work with stakeholders and suppliers to help drive business issues to resolution.  Understand contractual / financial implications of issues and solutions and ensure appropriate outcomes are implemented.  Manage and communicate forecasts to the sites.  Support capacity planning activities.

• Manage CMO Performance. Measure and report on the overall performance of each CMO.  Identify and drive performance improvements (COGS, cycle time, quality, etc.) to ensure efficient, reliable supply of all clinical and commercial products.

• Work collaboratively with Project Management to ensure projects from conception to implementation and close-out, as directed by management.

• Serve as Revolution Medicines’ primary business operation lead and project management interface between internal PDM functions and CRDMOs for drug product and finished product by providing adequate oversight.

• Ensure projects/programs meet desired results, compliance, speed, quality, and cost.

• Support cross-functional CRDMO management activities, covering all aspects such as business needs identification, market screening, contracting, vendor qualification and set-up, compliant delivery of services, and discontinuation.

• Work with PDM senior management and cross-functional teams to assess and manage supplier performance through use of personal influence, internal business review meetings, and/or joint governance meetings.

• Identify and deliver on cost savings opportunities.

Required Skills, Experience and Education:

• B.Sc. or M.Sc. in scientific field with 15+ years of experience in pharmaceutical strategic sourcing and/or supply chain.

• Experience working with domestic and international CRDMOs.

• Experience managing both strategic and tactical/operational projects.

• Working knowledge of and experience in clinical manufacturing, regulatory, QA, and cGMP requirements for small molecules.

• Working knowledge of small molecule drug development and commercialization, including, but not limited to, oral solid dosage form development and manufacturing, scale-up, and validation.

• Working knowledge of pharma end-to-end supply chain, with oral solid dosage form related supply a plus.

• Strong negotiation skills.

• Solid project management, facilitation, and problem solving skills.

• Solid organizational and time management skills.

• 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.

• Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.

Preferred Skills:

• Experience in implementing and/or managing inventory management system.

• Working knowledge of commercial manufacturing.

• Experience developing, negotiating, and executing clinical or commercial supply and/or quality agreements.

• Working knowledge of small molecule drug development and commercialization, including, but not limited to, oral solid dosage form development and manufacturing, scale-up, and validation.

• Working knowledge of pharma end-to-end supply chain, with oral solid dosage form related supply a plus.

• Strong negotiation skills.

• Solid project management, facilitation, and problem solving skills.

• Solid organizational and time management skills.

• 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.

• Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.

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