Associate Director – Manufacturing Package Design

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $129k - $231k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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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 small molecule solid oral dosage forms supporting late-stage clinical and commercial manufacturing programs • Serve as the manufacturing/CMC packaging design lead 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 align clinical trial packaging and labeling 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 such as design history files, packaging specifications, and 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 • Collaborate with Manufacturing, Quality, Supply Chain, and Commercial teams to support launch readiness, commercial supply continuity, and product lifecycle management • Identify, lead, and implement continuous improvement initiatives for packaging processes, equipment, and vendor performance • Manage packaging-related change controls, deviations, and CAPAs with Quality; support root cause investigations • Evaluate and select packaging materials, components, and equipment with CMOs/CPOs and suppliers • Support qualification of new suppliers and packaging lines • Provide packaging design expertise for 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 related to packaging design and engineering • Report to the Vice President, CMC • 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 • Demonstrated 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 • Advanced degree preferred • Experience authoring or reviewing CMC packaging sections of regulatory submissions preferred • Experience with combination products/device packaging preferred, as applicable

🏖️ Benefits

• Company bonus depending 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 • Certain time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities