Senior Director, Analytical Development CMC

🔥 0 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 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 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 • Save and store documentation; generate stability result tables; file stability data for expiry and shelf-life assignments • Lead specification setting based on batch history and analytical data • Serve as the CMC analytical representative on program development teams • Act as a subject matter expert and role model for junior analytical scientists • Contribute to analytical CMC aspects of regulatory filings, including regulatory starting material justifications, specification justifications, 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 • Respond to regulatory requests for information • Work cross-functionally with Quality on analytical OOE/OOT/OOS investigations, deviations, and troubleshooting • Participate actively in batch record review • Travel to domestic and international vendors as required

🎯 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, 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-making and communication skills; 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, 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 • Employee resource groups open to all employees