Associate Director, Manufacturing Package Design

🔥 27 minutes 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 • Represent the company as manufacturing/CMC packaging design lead on project teams with external CMOs/CPOs • Manage packaging-related technical relationships, including periodic site visits • 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 designs and processes from development/clinical scale to commercial manufacturing • Lead line trials, engineering runs, and scale-up activities • Develop and maintain design history files, packaging specifications, risk assessments/FMEAs, and other technical documentation in accordance with cGMP and design control requirements • Author and review CMC packaging sections of regulatory submissions and respond to health authority packaging queries • Collaborate with Manufacturing, Quality, Supply Chain, and Commercial teams on launch readiness, commercial supply continuity, and lifecycle management • 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 qualification of suppliers and packaging lines • Support development of quality systems, processes, and procedures • Build, lead, and mentor a team supporting manufacturing package design • Provide subject matter expertise during regulatory inspections and audits

🎯 Requirements

• Bachelor's degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or a related field; advanced degree preferred • 7+ years’ experience in sponsor-side manufacturing package design, with 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 • Experience authoring or reviewing CMC packaging sections of regulatory submissions preferred • Experience with combination products/device packaging preferred, as applicable • Strong leadership, project management, and cross-functional collaboration skills • Ability to exercise judgment within broadly defined practices and policies in determining solutions and actions • Ability to identify and address packaging-related technical or quality issues that could jeopardize schedule, supply, or overall program success • Domestic and international travel required, approximately 10–20%

🏖️ Benefits

• Company bonus depending on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • 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