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Senior Advisor Manufacturing Package Design

Job in Fishers, Hamilton County, Indiana, 46037, USA
Listing for: Eli Lilly and Company
Full Time position Listed on 2026-11-09
Job specializations:
  • Manufacturing / Production
    Packaging Engineer, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 144000 - 251000 USD Yearly USD 144000.00 251000.00 YEAR

Job Description & How to Apply Below

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.

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX
750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work
® in 2026.

We are currently seeking an Senior Advisor, Manufacturing Package Design. This individual will lead the design, development, and technical strategy for primary and secondary packaging supporting late-stage clinical and commercial-stage drug product manufacturing. Reporting to the Vice President, CMC, this role will provide technical and strategic leadership for packaging systems, ensuring solutions meet quality, regulatory, and commercial manufacturing readiness requirements. This individual will partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, and Supply Chain, as well as external Contract Manufacturing/Packaging Organizations (CMOs/CPOs), to drive packaging design, qualification, and launch readiness for late-stage development programs.

Responsibilities
  • Lead the design, development, and technical strategy for primary and secondary packaging components/systems for small molecule solid oral dosage forms (e.g., container closure systems including bottles and blisters, and blister wallet configurations where applicable) supporting late-stage clinical and commercial manufacturing programs.
  • Serve as the manufacturing/CMC packaging design lead representing the company on project teams with external CMOs/CPOs; manage packaging-related technical relationships, including periodic site visits as required.
  • Partner with CMC and Clinical Supply Chain to ensure proper clinical trial packaging and labeling are aligned with production forecasts and product demand
  • Direct packaging engineering activities, including design verification/validation, transportation and shipping validation, stability packaging configurations and compatibility studies.
  • Lead technology transfer of packaging design and processes from development/clinical scale to commercial manufacturing, including line trials, engineering runs, and scale-up activities.
  • Develop and maintain technical documentation supporting packaging design (e.g., design history files, packaging specifications, risk assessments/FMEAs) in accordance with cGMP and applicable design control requirements.
  • Partner with Regulatory Affairs to author and review CMC packaging sections of regulatory submissions and respond to health authority queries related to packaging.
  • Collaborate with Manufacturing, Quality, Supply Chain, and Commercial teams to ensure packaging design supports launch readiness,…

Position Requirements

10+ Years work experience
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