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Eli Lilly is seeking a Director of Manufacturing CMC (Chemistry, Manufacturing, and Controls) Project Management to lead the commercialization lifecycle for pharmaceutical products at its newly established $1B+ Manufacturing and Quality Technical Hub in Hyderabad, India.
This is a strategic leadership role with full accountability for a product's entire commercialization journey—from post-Phase 2 through launch and beyond. You will own the manufacturing CMC strategy, lead the Product Core Team, and serve as the primary interface between technical functions and senior executives. This is not a coordination role; it demands deep pharmaceutical development and manufacturing expertise, executive presence, and the ability to drive alignment across a complex, matrixed organization without direct authority.
Key Responsibilities:
- Own the Manufacturing CMC Commercialization Strategy across Development, Manufacturing, and Business Units, ensuring clear ownership, milestone accountability, and proactive risk management.
- Lead the Product Core Team and oversee technical execution; serve as the accountable representative at all Governance and Oversight Forums.
- Act as the primary interface for senior executives, translating technical complexity into concise, actionable insight and surfacing escalations proactively.
- Ensure sustained alignment across Development, Manufacturing, Business Units, global manufacturing sites, and CMC Regulatory throughout the product lifecycle.
- Influence without authority across a complex, matrixed organization—building trust, resolving conflict, and driving decisions through collaboration.
- Partner closely with Development and CMC Regulatory on submission strategy to ensure the manufacturing program supports regulatory timelines.
- Lead Post-Launch Technical Agenda (PLTA) strategy, ensuring long-term commercial and technical sustainability through proactive planning for process improvements and continuous optimization.
- Demonstrate proficiency in enterprise project management, collaboration, and reporting tools to drive transparency and execution excellence.
Success in Year One:
You will have demonstrated stakeholder orchestration credibility, synthesized a manufacturing technical agenda as the single source of truth, resolved at least one major bottleneck through smart convening, earned senior leader confidence in your visibility into product status, and accelerated the product team's speed and purpose.
Required Qualifications:
- Advanced degree (M.S., Ph.D., or MBA with strong technical foundation) in engineering or science. Bachelor's degree with equivalent industry experience may be considered.
- 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 without direct authority across complex, matrixed organizations.
- Track record of operating effectively at the senior leadership level—communicating with confidence, handling ambiguity, and making high-quality decisions under pressure.
- Functional background in one or more areas preferred: TS/MS, CMC development, Operations, Supply Chain, or Manufacturing.
Key Skills & Competencies:
- Strategic Leadership: shapes long-range manufacturing CMC commercialization strategy; translates vision into execution.
- Influence Without Authority: drives alignment and decisions across powerful, matrixed stakeholders without formal reporting relationships.
- Change Leadership: leads teams through organizational, technical, and strategic change while maintaining stakeholder engagement and execution momentum.
- Executive Communication: distills complex technical and operational information into clear, confident narratives for senior audiences.
- Negotiation & Conflict Resolution: balances competing functional and affiliate priorities with fairness, speed, and strategic judgment.
- Commercial Acumen: understands the business implications of manufacturing decisions—including supply risk, launch readiness, and lifecycle value.
- Risk Management: proactively identifies, surfaces, and resolves program risks before they become schedule or quality issues.
- Cross-Cultural & Global Collaboration: effective working across global manufacturing sites, development organizations, and business units with varying priorities.
- Entrepreneurial Mindset: comfortable operating in an evolving role structure; builds credibility and process from the ground up.
Flexibility required to support critical business discussions outside standard local working hours to meet global business needs.
