PHARMAFull-time
Director - Manufacturing CMC Project management
By Admin · Regulatory Affairs
HYDERABAD (IN)ONSITEPOSTED: 9/13/2026
PHARMAFull-time
HIRING ORGANIZATIONELI LILLY AND COMPANYPharmaceuticals and Biotechnology
ROLE OVERVIEW
Own the end-to-end Manufacturing CMC commercialization strategy for assigned pharmaceutical products from post-Phase 2 through launch and beyond. Lead cross-functional product teams, drive executive visibility, manage risks and align development, manufacturing, supply chain and regulatory stakeholders.
ROLE DEFINITION & RESPONSIBILITIES
- •Own the Manufacturing CMC Commercialization Strategy across Development, Manufacturing and Business Units
- •Lead the Product Core Team with milestone accountability and proactive risk management
- •Drive alignment on launch presentation and commercial image strategy
- •Ensure governance deliverables, plans and execution remain on track
- •Represent the product at governance and oversight forums and provide executive-level visibility
- •Align global manufacturing, development, business-unit and CMC Regulatory stakeholders
- •Lead Post-Launch Technical Agenda strategy and lifecycle-management planning
- •Identify and resolve bottlenecks, risks and gaps affecting launch readiness and product sustainability
Reporting Hierarchy: Reports to the relevant Lilly Manufacturing/CMC leadership organization; Leads the Product Core Team and collaborates with Development, Manufacturing, Business Units, Supply Chain, Manufacturing Sites and CMC Regulatory
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Advanced engineering or scientific degree such as M.S. or Ph.D., or MBA with strong technical foundation
- Minimum 8 years of progressive pharmaceutical industry experience
- Meaningful exposure to development, manufacturing, commercialization or technical program leadership
- Experience with both drug substance and drug product
- Experience with small or large molecule products
- Experience leading cross-functional programs through development and commercialization milestones
- Ability to evaluate manufacturing network strategies and impacts on launch readiness, supply continuity, cost and lifecycle management
- Proven ability to influence without direct authority in complex matrixed organizations
PREFERRED QUALIFICATIONS
- •Advanced degree preferred
- •Experience in TS/MS, CMC development, Operations, Supply Chain or Manufacturing
- •Experience with tech transfer, process validation, regulatory submission readiness and product launch
- •Senior leadership communication experience
- •Experience with post-launch technical agenda and continuous manufacturing optimization
REQUIRED VERIFIED SKILLS
Manufacturing CMC strategy
CMC commercialization
pharmaceutical development
drug substance
drug product
technical program management
product core team leadership
commercialization milestones
tech transfer
process validation
regulatory submission readiness
product launch
lifecycle management
risk management
executive communication
stakeholder management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Employee development, professional growth, disability accommodation support and a purpose-driven work environment
The posting does not disclose a salary range or bonus/equity amount. Compensation should therefore be treated as undisclosed.
ORGANIZATION CONTEXT & CULTURE
Eli Lilly and Company is a global pharmaceutical company focused on discovering and delivering life-changing medicines. Lilly operates a global manufacturing network and is investing more than $1 billion in its Hyderabad Manufacturing and Quality Technical Hub.
TEAM SIZE: 50,000+ employees
INDUSTRY: Pharmaceuticals and Biotechnology
Culture: Purpose-driven culture centred on patient impact, innovation, excellence, integrity, respect and collaboration across global teams.
EXPECTED CAREER ROADMAP
The role can progress toward senior executive leadership across Manufacturing CMC, technical operations, global product commercialization, supply chain or broader pharmaceutical operations. It provides exposure to enterprise-level strategy, governance and global product lifecycle ownership.
APPLICATION ADVISORY
Emphasize 8+ years of pharmaceutical industry experience and senior CMC or manufacturing leadership; demonstrate experience across drug substance and drug product; highlight ownership of commercialization, tech transfer, process validation or launch programs; show influence without authority in matrix organizations; quantify major risks resolved, launches supported or operational improvements; emphasize executive-level communication and global stakeholder leadership.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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