Director - Manufacturing CMC Project management

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. Company Overview Lilly, a leading innovation-driven corporation is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world’s most urgent medical needs. Founded over 150 years ago, the company has sustained a culture that values excellence, integrity and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work. Lilly knows its business has prospered because of its employees – people with a talent for innovation and a passion for making a difference by finding treatments for the most stubborn diseases; people whose talent is matched by their generosity, and people with strong values and a determination to prevail, regardless of the challenges. Join our team – and make a difference in improving health for people all over the world! Manufacturing and Quality Technical Hub Hyderabad Lilly has made a strategic investment of more than $1B dollars to establish a Manufacturing and Quality technical hub. This hub will oversee the significant investment in contract manufacturing of starting materials and intermediates for API manufacturing in India and the technical services responsible for managing the scientific agenda for manufacturing and quality. The hub will be recruiting top talent in the areas of process engineering, chemistry, analytical and data sciences to build a cutting-edge scientific organization supporting the exciting manufacturing portfolio of Lilly. About This Role Lilly’s product commercialization spans a growing global manufacturing network, dozens of specialized functions, and an expanding portfolio of transformative medicines. The gap: no single leader owns the full picture. This role fills that gap. You are the single point of accountability for a product’s entire commercialization lifecycle—from post-Phase 2 through launch and beyond. You own the manufacturing CMC strategy, lead the Product Core Team, collaborate with development, and serve as the go-to interface for senior executives who need clarity, not noise. This is a strategic leadership role, not a coordination role. It demands deep pharma development and/or manufacturing knowledge, executive presence, and the ability to drive alignment across a powerful, matrixed organization — without direct authority. What Success Looks Like in Year One Lilly’s commercialization process involves deep, specialized functions — Development, Engineering, Analytical Quality, TS/MS, Supply Chain, Manufacturing Sites, and CMC Regulatory. Each brings critical expertise. The winning Manufacturing CMC Project Manager orchestrates them: knowing when to convene the full team, and when to engage only who’s needed — protecting expert time and driving efficient progress. In year one, you will have demonstrated: Stakeholder orchestration credibility — functional leaders trust that when you call them in, it matters; when you don’t, it’s handled. A Mfg technical agenda that serves as the true single source of truth — every relevant function’s input synthesized into one coherent product strategy. At least one major bottleneck resolved through smart, targeted convening — the right people in the room, no one else. Senior leaders who say you “always know where the product stands” — earned through disciplined intelligence-gathering, not reporting overhead. A product team operating with more speed and purpose than before — siloed expertise channeled into coordinated, forward momentum. Key Responsibilities Manufacturing CMC Strategy & Commercialization Ownership Own the Manufacturing CMC Commercialization Strategy across Development, Manufacturing, and Business Units. Lead the Product Core Team and oversee its technical execution, ensuring clear ownership, milestone accountability, and proactive risk management. Drive alignment of launch presentation and commercial image strategy across relevant functional and affiliate stakeholders. Ensure gate deliverables are clearly defined, plans are in place, and execution is on track; proactively identifying and resolving gaps. Governance & Executive Visibility Serve as the accountable representative for the product at all Governance and Oversight Forums, providing clear, confident updates on progress, risks, and decisions required. Act as the primary interface for senior executives seeking visibility into commercialization status — translating technical complexity into concise, actionable insight. Ensure escalations are surfaced proactively and resolved with appropriate speed and rigor. Demonstrates proficiency in using enterprise project management, collaboration, and reporting tools to drive transparency and execution excellence. Cross-Functional Alignment & Stakeholder Leadership Ensure sustained alignment across Development, Manufacturing, and Business Unit stakeholders throughout the product’s lifecycle, including global manufacturing site teams and CMC Regulatory. Influence without authority across a complex, matrixed organization — building trust, resolving conflict, and driving decisions through collaboration rather than directive. Partner closely with Development and CMC Regulatory on submission strategy, ensuring the manufacturing program supports regulatory timelines and requirements. Post-Launch Technical Agenda Lead Post-Launch Technical Agenda (PLTA) strategy for assigned products, influencing pre-submission deliverables and lifecycle management planning. Ensure the product’s long-term commercial and technical sustainability by driving proactive planning for process improvements, line extensions, and continuous manufacturing optimization. Required Qualifications Education Advanced engineering, scientific degree (M.S., Ph.D., or MBA with strong technical foundation). Advanced degrees are preferred although a Bachelor with equivalent industry experience may also be considered. Experience Minimum 8 years of progressive pharmaceutical industry experience, with meaningful exposure to development, manufacturing, commercialization, and/or technical program leadership. Experience with both drug substance and drug product. Small or large molecule experience. Demonstrated experience leading or significantly contributing to cross-functional programs through key development and commercialization milestones (e.g., tech transfer, process validation, regulatory submission readiness, product launch). Ability to evaluate manufacturing network strategies and their impact on launch readiness, supply continuity, cost, and lifecycle management. Proven ability to influence and lead w