Senior Director, Drug Product CMC

🔥 12 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

• Directly manage external vendors, including Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) • Execute physicochemical characterization and pre-formulation studies for New Chemical Entities (NCEs) • Design and develop nonclinical formulations for oral, subcutaneous, and intravenous drug candidates • Ensure formulation stability, bioavailability, and effective drug delivery in animal models • Design and oversee nonclinical formulation stability and compatibility studies • Support clinical formulation development of oral solid dosage forms as needed • Author, review, and approve development and dose preparation protocols and reports • Review formulation-related sections of protocols and reports associated with PK, PD, and safety studies • Represent CMC and provide nonclinical formulation, DS and DP stability, and supply guidance at internal and external cross-functional team meetings • Coordinate shipments supporting nonclinical and clinical development supply requirements to CDMO and CRO sites • Assist in compiling formulation-related documentation for regulatory submissions, including IND and CTA filings • Collaborate with discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality, regulatory, and other CMC functions • Report to the Executive Director, CMC

🎯 Requirements

• Advanced degree in Chemistry, Pharmaceutical Sciences, or a related discipline; Ph.D. is strongly preferred • 10+ years of drug product/formulation development experience supporting nonclinical and clinical programs • Expertise across oral, subcutaneous, and intravenous dosage forms for small molecules • Deep technical expertise in the development and manufacture of poorly soluble (BCS Class II/IV) compounds • Strong understanding of pharmaceutical sciences and engineering principles related to liquid and solid dosage form development from early-stage development through clinical and commercial manufacturing • Working knowledge of analytical and solid-state characterization techniques, including HPLC/UPLC, XRPD, DSC, TGA, DVS, and related methodologies • Experience managing external development and manufacturing partners (CROs, CDMOs, and CMOs) • Solid understanding of cGMP requirements • Proven ability to lead multiple complex programs in a fast-paced environment • Strong project management, prioritization, resource management, and organizational skills • Excellent communication, presentation, and interpersonal skills • Ability to influence stakeholders, build productive internal and external partnerships, and communicate complex scientific concepts to diverse audiences • Strategic, hands-on leadership with strong decision-making and problem-solving capabilities • Demonstrated resilience and track record of delivering high-quality results with urgency and integrity • Willing and able to travel domestically and internationally as needed

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