Director, External Quality Control – Stability

Job not on LinkedIn

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $117k - $259.6k / year

⏰ Full Time

🔴 Lead

👔 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

• Develop and lead analytical quality control strategy across multiple programs • Review analytical methods, specifications, and validation activities and collaborate on updates • Support analytical method transfer • Collaborate on supplier qualification and/or remediation activities • Oversee stability program design and execution across multiple programs • Monitor and report on stability trends and product quality attributes • Ensure ongoing regulatory compliance of stability activities • Manage ongoing supplier relationships • Perform routine reviews of testing results and quality documentation • Drive issue resolution to facilitate regulatory compliance • Provide tactical support for regulatory submissions • Support health authority inspections and audits • Review analytical and stability sections within CMC filings

🎯 Requirements

• BS/MS/PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field • 10+ years quality control and analytical development experience • Experience developing strategic vision and providing tactical support for quality control programs

🏖️ Benefits

• Company bonus depending in part 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