Associate Director, Drug Product CMC

🔥 5 minutes ago

🇺🇸 United States – Remote

💵 $129k - $231k / 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

• Manage and guide external vendors, including CROs and CDMOs • Execute physicochemical characterization and pre-formulation studies for New Chemical Entities • Design and develop nonclinical oral, subcutaneous, and intravenous formulations for stability, bioavailability, and effective 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 for 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 submissions • Collaborate with discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality, regulatory, and other CMC functions • Occasionally travel to domestic and international vendors

🎯 Requirements

• BS or MS in Pharmaceutical Sciences or a related scientific discipline required; PhD strongly preferred • 7+ years of experience in small molecule formulation development, including support of nonclinical and clinical programs across oral, subcutaneous, and intravenous dosage forms • Deep understanding of formulation development and manufacturing of poorly soluble (BCS Class II/IV) small molecule compounds for oral, subcutaneous, and intravenous delivery • Strong knowledge of pharmaceutical and engineering principles related to liquid and solid dosage form development at clinical and commercial scale • Proficiency with analytical and solid-state characterization techniques, including HPLC/UPLC, XRPD, DSC, TGA, DVS, and related methodologies • Experience managing external development partners (CROs, CDMOs, CMOs) and coordinating pharmaceutical product development activities • Working knowledge of cGMP requirements and pharmaceutical development standards • Strong strategic, analytical, and problem-solving skills, with the ability to anticipate risks, develop contingency plans, and drive timely, high-quality results • Excellent communication, interpersonal, and project leadership skills, with the ability to influence stakeholders, manage cross-functional and external relationships, and effectively communicate complex concepts to diverse audiences • Highly organized, detail-oriented, and self-directed, with the ability to manage multiple priorities and perform effectively in a fast-paced, dynamic environment • Willingness to travel domestically and internationally (5–10%)

🏖️ 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 • Employee resource groups open to all employees