Senior Director, Analytical Development, CMC

🔥 13 hours 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 related to phase-appropriate method development, validation, and product characterization for multiple programs • Lead drug substance and drug product analytical development activities at third-party vendors, including method implementation, qualification/validation, and transfer, supporting pre-IND through registrational programs • Review method validation protocols and reports, and test data for release, stability, and characterization • Save and store documentation, generate stability result tables, and file stability data for expiry and shelf-life assignments • Lead specification setting based on batch history and supporting analytical data • Serve as the CMC team analytical representative on program development teams • Act as a role model and subject matter expert for junior analytical scientists • Contribute to CMC analytical aspects of regulatory filings, including regulatory starting material justifications, specification justifications, discriminatory and quality control dissolution method development, and structural elucidations • Review and draft internal technical reports and analytical sections of global submission documents and modules, including IND, IMPD, NDA, and MAA, and responses to regulatory information requests • Work cross-functionally with Quality as a technical expert on analytical OOE/OOT/OOS investigations, deviations, and troubleshooting • Participate actively in batch record review • Drive analytical method gap assessments, method development, and strategy at CDMOs • Liaise cross-functionally with drug substance and drug product teams across programs • Ensure analytical CMC data from external CDMOs meets 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 (e.g., genotoxic, 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, including assay development, stability, and quality control at CDMOs • Hands-on experience designing, managing, and interpreting stability programs (real-time, accelerated, and forced degradation) • Strong understanding of product quality attributes and control strategies for small molecule synthetic processes • Demonstrated leadership in coordinating analytical and broader CMC activities supporting development and commercialization • Excellent project management, organizational, and prioritization skills in fast-paced, multi-project environments • 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, in part, 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 • Certain time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities