Senior Advisor – Manufacturing Package Design

🕒 September 8

🇺🇸 United States – Remote

💵 $144k - $250.8k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 31%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Lead the design, development, and technical strategy for primary and secondary packaging systems for late-stage clinical and commercial manufacturing programs • Serve as manufacturing/CMC packaging design lead on project teams with external CMOs/CPOs and manage technical relationships • Partner with CMC and Clinical Supply Chain on clinical trial packaging and labeling aligned with forecasts and demand • Direct packaging engineering activities, including design verification/validation, transportation and shipping validation, stability packaging configurations, and compatibility studies • Lead technology transfer from development/clinical scale to commercial manufacturing, including line trials, engineering runs, and scale-up • Develop and maintain technical documentation such as design history files, packaging specifications, and risk assessments/FMEAs • Author and review CMC packaging sections of regulatory submissions and respond to health authority queries • Collaborate across Manufacturing, Quality, Supply Chain, and Commercial teams to support launch readiness and supply continuity • Lead continuous improvement initiatives for packaging processes, equipment, and vendor performance • Manage packaging-related change controls, deviations, and CAPAs; support root cause investigations • Evaluate and select packaging materials, components, and equipment; support supplier and packaging-line qualification • Support development of quality systems, processes, and procedures • Build, lead, and mentor a team supporting manufacturing package design activities • Provide subject matter expertise during regulatory inspections and audits • Travel domestically and internationally approximately 10–20%

🎯 Requirements

• Bachelor's degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or a related field • 7+ years’ experience in sponsor-side manufacturing package design • Demonstrated leadership of packaging design programs • Significant experience supporting late-stage clinical and/or commercial packaging programs • Strong knowledge of cGMP regulations and industry standards/trends pertaining to pharmaceutical packaging design, container closure systems, and manufacturing • Experience leading packaging technical strategy and design for late-stage/commercial programs, including technology transfer to commercial manufacturing • Experience managing relationships with CMOs/CPOs and packaging component/material suppliers • Working knowledge of drug substance, drug product, and packaging principles, equipment, and processes across solid dosage and/or parenteral formats • Strong leadership, project management, and cross-functional collaboration skills • Demonstrated ability to identify and address packaging-related technical or quality issues that could jeopardize schedule, supply, or overall program success

🏖️ Benefits

• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities

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