Associate Director; External Supply Chain, Clinical Drug Product
PharmaClinical ResearchRegulatory AffairsQuality Assurancegmpemacroraveinform
Job description
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Overview: At Lilly, we serve an extraordinary purpose. For nearly 150 years we have worked tirelessly to discover medicines that make life better. In Product Research and Development (PRD), we transform molecules into medicines, advancing one of the most diverse and promising pipelines in the industry. PRD’s External Supply Chain & Operations (ESCO) team stewards PRD's external partner network — delivering supplier excellence, systematic and scalable sourcing workflows, supply chain design, technical-transfer processes, and end-to-end network performance across drug substance, drug product, and analytical services. This role is responsible for sourcing clinical (Phase 1–3) drug product manufacturing capacity across the PRD portfolio, with a primary focus on parenteral manufacturing and a supporting focus on solid oral manufacturing. The role serves as the connective link between CM&C (Chemistry, Manufacturing & Controls) teams, who define project manufacturing needs, and the network of contract manufacturing organizations (CMOs) that supply that capacity — managing the sourcing lifecycle from needs assessment through vendor recommendation and ongoing vendor relationship management. Key Responsibilities End-to-End Clinical Drug Product Sourcing Partner with Clinical GMP DP supply group and CM&C teams to assess clinical drug product manufacturing needs and match those needs against Lilly's portfolio of contract manufacturing partners, based on capability, capacity, and modality fit, including assessment of internal manufacturing capacity where applicable. Lead Drug Product RFP authoring working with technical subject matter experts across PRD (CM&C, CSD, BRD, and SMDD); partner with Procurement on sourcing process and evaluation of proposals. Serve as the DP Supply Chain resource for external CMOs during the sourcing process. Lead review of proposals and generate external sourcing recommendations in partnership with program team, functional leadership, and Procurement. Supply Chain Operations Contribute to and help ensure network-wide adherence to PRD Drug Product guidance documentation and standards, including RFx, Due Diligence, Technical Transfer, and CMO Operational KPIs. Continuously assess the drug product manufacturing partner portfolio against current and forecasted PRD needs to identify gaps or emerging risk, leveraging dedicated sourcing intake tools and follow-up with CM&C project teams. Partner with Procurement to identify, RFI, and shortlist new manufacturing partners where portfolio gaps exist, and lead due diligence teams — including on-site visits — to assess candidate providers. Support the PRD DP Platform Strategies by filtering new vendor needs against established platform guidance where available, applying independent judgment where platform strategy has not yet been defined for a given drug product platform. Proactively track emerging manufacturing trends (new modalities, container closure systems, manufacturing technologies) to anticipate capability needs ahead of clinical demand. Support Phase 3 transition planning with Strategic Facilities Planning (SFP) to place projects with suppliers appropriate for eventual transition to Commercial Manufacturing. Vendor Relationship Management & Performance Serve as Alliance Manager for key Drug Product CMOs tiered as Critical or Leverage within the PRD Supplier Governance framework, in close partnership with Clinical Trial (CT) Manufacturing management, building strong, collaborative partnerships with contract manufacturers. Monitor and manage vendor performance metrics and communicate performance scorecards and business reviews with third-party manufacturing partners to support continued improvement and future sourcing decisions. Serve as a key point of contact for issue escalation and resolution with manufacturing partners, applying strong cross-cultural and cross-functional communication skills across national and organizational cultures. Digital Sourcing Systems & Data Stewardship Partner on the design, administration, and continuous improvement of digital sourcing and tracking systems used to manage clinical drug product manufacturing demand, capacity, and vendor performance data. Contribute vendor capability, capacity, and performance data toward a unified, centralized supplier tracking and capability database for the External Supply Chain & Operations network. Support the evaluation and adoption of emerging AI-enabled sourcing tools that improve partner-capability, capacity, and performance decision-making across the network. Basic Qualifications BS or MS in Pharmaceutics, Pharmacy, Formulation Science, Chemical Engineering, Pharmaceutical Sciences, or closely related STEM discipline required. BS graduates must have at least 8 years of relevant experience in pharmaceutical drug product R&D, GMP drug product manufacturing, and/or drug product supply chain. MS graduates must have at least 6 years of relevant experience in pharmaceutical drug product R&D, GMP drug product manufacturing, and/or drug product supply chain. Parenteral drug product manufacturing experience required. Additional Preferences Demonstrated experience managing external CMO relationships and working knowledge of clinical (Phase 1–3) drug product manufacturing and related CMC, Quality, Regulatory, and HSE requirements. Strong vendor relationship management, negotiation, and conflict-resolution skills; ability to communicate effectively across cultures and organizational levels, in both written and verbal formats. Experience leading supplier due diligence and qualification efforts, including on-site assessments. Ability to operate effectively in ambiguity, manage competing priorities, and adjust quickly to change. Additional information Travel: 10 to 20%. Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N). This is an on-site position. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. <p style="text-alig
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