Senior Director, Analytical Development CMC

🔥 27 minutes ago

🇺🇸 United States – Remote

💵 $153k - $290.4k / 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 analytical strategy for phase-appropriate method development, validation, and product characterization across multiple programs • Lead drug substance and drug product analytical development activities at third-party vendors, including method implementation, qualification/validation, and transfer • Review method validation protocols and reports, and release, stability, and characterization test data • Store documentation, generate stability result tables, and file stability data for expiry and shelf-life assignments • Lead specification setting based on batch history and analytical data • Represent analytical CMC on program development teams • Serve as a role model and subject matter expert for junior analytical scientists • Contribute to CMC analytical sections of regulatory filings and responses to regulatory information requests • Review and draft internal technical reports and analytical submission documents, including IND, IMPD, NDA, and MAA materials • Work cross-functionally with Quality on OOE/OOT/OOS investigations, deviations, and troubleshooting • Participate actively in batch record review • Manage analytical CMC data from external CDMOs to meet company deliverables and timelines • Travel to domestic and international vendors

🎯 Requirements

• Advanced degree in chemistry, pharmaceutical sciences, or related field (PhD strongly preferred) • 10+ years of small molecule pharmaceutical industry experience • Extensive experience in early phase analytical development of small molecule oral solid dosage forms • Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products • Strong technical background in chemical and physical characterization, including polymorphism, particle size, residual solvents, process impurities, genotoxic impurities, nitrosamines, and forced degradation mechanisms • Significant experience in analytical method development and GMP qualification/validation, including assay, related substances, and dissolution • Proven ability to manage and direct outsourced analytical activities at CDMOs • Hands-on experience designing, managing, and interpreting stability programs • Strong understanding of product quality attributes and control strategies for small molecule synthetic processes • Demonstrated leadership coordinating analytical and broader CMC activities supporting development and commercialization • Excellent project management, organizational, and prioritization skills • Strong analytical planning, resource management, and budget oversight skills across global CDMO networks • Effective decision-maker and communicator able to work independently while collaborating across functions and organizational levels

🏖️ 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 • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities