Senior Advisor, Manufacturing Package Design

🕒 2 days ago

🇺🇸 United States – Remote

💵 $144k - $250.8k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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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 global pharmaceutical company that researches, develops, manufactures, and distributes prescription medicines and provides patient support services. The company focuses on life-changing medicines across conditions such as diabetes, cancer, Alzheimer’s disease, autoimmune disorders, dermatology, migraine, obesity, and sleep apnea; it runs clinical trials, offers LillyDirect pharmacy services, and emphasizes manufacturing quality, medication safety, and research into genetic medicines. Eli Lilly also provides patient resources, condition education, and access programs to help people find care and participate in trials.

📋 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, and FMEAs 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, supply continuity, and product lifecycle management • Lead continuous improvement initiatives for packaging processes, equipment, and vendor performance • Manage packaging-related change controls, deviations, and CAPAs with Quality • Support root cause investigations related to packaging design or component performance • 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

🎯 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 • 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 • Ability to exercise judgment within broadly defined practices and policies in determining solutions and actions • Demonstrated ability to identify and address packaging-related technical or quality issues that could jeopardize schedule, supply, or overall program success • Experience authoring or reviewing CMC packaging sections of regulatory submissions preferred • Experience with combination products/device packaging preferred, as applicable • Willingness and ability to undertake domestic and international travel of approximately 10–20%

🏖️ Benefits

• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical benefits • Dental benefits • Vision benefits • Prescription drug benefits • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities • Disability accommodation support during the application process

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