Senior Director, Drug Product CMC

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $163.5k - $264k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 CROs and CDMOs • Execute physicochemical characterization and pre-formulation studies for New Chemical Entities • Design and develop nonclinical oral, subcutaneous, and intravenous formulations • 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 formulation, DS and DP stability, and supply guidance at cross-functional meetings • Coordinate shipments supporting nonclinical and clinical development supply requirements • Assist with 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 • Travel to domestic and international vendors

🎯 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 developing and manufacturing 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, including CROs, CDMOs, and CMOs • Solid understanding of cGMP requirements • Ability to lead multiple complex programs in a fast-paced environment, with project management, prioritization, resource management, and organizational skills • Excellent communication, presentation, and interpersonal skills • Strategic, hands-on leadership with decision-making and problem-solving capabilities • 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