Senior Director, Drug Product CMC

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $163.5k - $264k / 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 work with external vendors and oversee nonclinical formulation development across programs • Manage 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 drug delivery in animal models • Design and oversee nonclinical formulation stability and compatibility studies • Support clinical formulation development of oral solid dosage forms • Author, review, and approve development and dose preparation protocols and reports • Review formulation-related sections of PK, PD, and safety study protocols and reports • Represent CMC and provide nonclinical formulation, drug substance and drug product stability, and supply guidance at cross-functional meetings • Coordinate shipments supporting nonclinical and clinical development supply requirements to CDMO and CRO sites • Compile formulation-related documentation for IND and CTA regulatory submissions • Collaborate with discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality, regulatory, and other CMC functions • Report to the Executive Director, CMC • Travel to domestic and international vendors

🎯 Requirements

• Advanced degree in Chemistry, Pharmaceutical Sciences, or a related discipline; Ph.D. 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 developing and manufacturing poorly soluble BCS Class II/IV compounds • Formulation strategies for oral and parenteral delivery • Strong understanding of pharmaceutical sciences and engineering principles for liquid and solid dosage form development through clinical and commercial manufacturing • Working knowledge of HPLC/UPLC, XRPD, DSC, TGA, DVS, and related analytical and solid-state characterization methodologies • Experience managing CROs, CDMOs, and CMOs • Solid understanding of cGMP requirements • Ability to lead multiple complex programs in a fast-paced environment • Project management, prioritization, resource management, and organizational skills • Excellent communication, presentation, and interpersonal skills • Ability to influence stakeholders, build internal and external partnerships, and communicate complex scientific concepts to diverse audiences • Strategic, hands-on leadership, decision-making, problem-solving, resilience, and high-quality delivery • Willingness and ability to travel domestically and internationally as needed

🏖️ Benefits

• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities • Employee resource groups and support networks