Associate / Manager – CMC Regulatory and IMP Manufacturing 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.

Organization Overview

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 35,000 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.

Responsibilities

The Associate / Manager, CMC Regulatory and IMP Manufacturing Operations is a hybrid role within CMC Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and document lifecycle management within IMP manufacturing operations. This position supports Lilly/Avid diagnostic radiopharmaceutical products globally.

• Support CMC change management, including change control issuing and assessments, as well as task management to ensure compliance with quality management systems
• CMC regulatory operations (e.g., coordinate regulatory submission timelines, manage regulatory documents, prepare content plans for regulatory submissions, and maintain submission information according to the Regulatory Information Management (RIM) system)
• Manage the preparation, review, and submission of global CMC regulatory dossiers and information request responses according to CMC regulatory strategies
• Author, revise, and/or review technical documentation including but not limited to testing protocols, technical reports, and standard operating procedures
• Participate as an active member of cross-functional teams and ensure alignment of global regulatory strategies with CMC development and commercial plans
• Support the establishment and maintenance of infrastructure tools, procedures, and systems for CMC regulatory and CMC development
• Keep current with global regulatory guidelines applicable to CMC
• Perform other duties as assigned
  
  
  

Basic Requirements

• Bachelor’s degree in a scientific discipline
• Minimum of 1 year of experience in pharmaceutical development, manufacturing, CMC regulatory, project management, and/or related field
  
  
  

Additional Skills/Preferences

• Organized and detail-oriented
• Strong communication skills with ability to work within global multi-disciplinary teams
• Excellent technical writing skills
• Ability to plan, prioritize, and handle multiple tasks concurrently
• Ability to independently complete assigned workload with minimum supervision
• Ability to adapt to change and work in a fast-paced environment
• Strong MS Office skills
  
  
  

Additional Information

• Must be willing and able to travel within the USA and worldwide 10% of time
  
  
  

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

$61,500 - $143,000

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.

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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