Manager, CMC Operations

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.

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
  
  
  

Required Qualifications

• 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%
  
  
  

Desired Qualifications

• 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
  
  
  

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$65,250 - $145,200

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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