Manager, CMC Operations

Eli Lilly and Company • Philadelphia, PA

2d • $65,250 - $145,200

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Position Overview: The Manager, CMC Operations is responsible for independently managing technical transfer projects to establish, maintain, and grow the successful, uninterrupted manufacturing of Lilly’s radiopharmaceutical drug products for clinical trial use at external contract manufacturing organizations (CMOs). This role will lead projects from the start of the technology transfer process through approval of the applicable regulatory filing.

Requirements

• B.S. in Chemistry or related field
• Minimum of 5 years of pharmaceutical industry experience
• At least 3 years of pharmaceutical CMC experience
• Must be fully conversant in cGMPs and regulatory requirements
• Must have experience in technical transfer activities and/or PET drug / radiopharmaceuticals
• Ability to travel 0-10%

Nice To Haves

• Ability to work independently in a highly focused manner
• Impeccable organizational skills
• Superior written and verbal communication skills
• Familiarity with project management tools such as MS Project, Smartsheet, Monday, Jira, etc.
• Proficiency in the Microsoft 365 environment

Responsibilities

• Independently manage multiple complex technology transfer projects related to the manufacturing and testing of Lilly products at external CMO sites
• Serve as the primary point of contact for technical transfer of manufacturing processes to CMO sites as well as corresponding site qualification, activation, and maintenance
• Lead and participate in cross-functional teams for technical transfer projects
• Provide periodic reports and/or presentations to internal team leaders for visibility into project progress and adherence to overall project timelines
• Generate, maintain, and present detailed project timelines using project management tools
• Author and review technical documents including standard operating procedures, testing protocols, technical reports, batch files and technical transfer documents for Lilly and CMOs
• Support the CMC team in ensuring that internal and external manufacturing and testing procedures and specifications comply with applicable cGMPs and local regulatory guidance and filings
• Maintain and develop comprehensive technical knowledge of manufacturing processes, equipment, and analytical methodologies integral to deployed products
• Be a key resource for manufacturing operations and analytical troubleshooting at CMOs
• Demonstrate a commitment to developing around Team Lilly
• Assumes other duties as assigned

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees