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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.

Company Overview

Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly-owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing diagnostics and biomarkers that improve global health by accelerating the development of new medicines and enabling a tailored approach to healthcare.

Position Overview

The Technical Operations Associate is responsible for troubleshooting production issues with Commercial US Contract Manufacturing Organization (CMO) sites, assisting with test method and production process changes, tracking production failure root causes, helping to implement improvements aimed at correcting production problems, providing technical input for production changes, and reviewing CMO investigations.

Responsibilities

• Assist/Lead investigations into defects and failures in the field at US Commercial Manufacturing Sites.
• Troubleshoot Quality Control (QC) test method and production issues with CMO sites for the assigned region. Coordinate with the Radiochemistry & Radiopharmaceutical Development and Analytical Development and Quality Control teams as necessary.
• Identify and track root causes for production failures and support programs /solutions to improve site production performance.
• Conduct site visits to assigned CMO sites to troubleshoot issues and/or to observe production and testing of Avid products and review for compliance with Avid approved procedures and PET GMP regulations.
• Assist with supplemental training of CMO site staff during site visits to correct deficiencies
• Assist with roll out of revised major QC test procedures or production processes to CMO
• Lead data analysis projects for batch data for global CMOs for all products
• Create technical summaries and trending reports based off all incoming batch data.
• Support projects related to management of incoming batch data for global CMOs for all products
• Review and assess all changes to technical documents and for process improvement discussions with the CMOs
• Author technical documents including but not limited to testing protocols, technical reports, and SOPs
• Review completed manufacturing batch documentation
• Support technology transfer and new site start-up as needed

Basic Qualifications

• Bachelor’s degree in a scientific or technical area

Additional Skills/Preferences

• Advanced degree preferred in a scientific or technical area
• Experience working with Radiopharmaceuticals
• Knowledge of cGMP drug substance/drug product manufacturing and quality control
• Impeccable organizational skills
• Ability to work independently in a highly focused manner
• Excellent interpersonal skills and ability to collaborate with internal and external parties
• Superior written and verbal communication skills
• Excellent computer skills (e.g. Excel, Word, and PowerPoint)

Additional Information

• Must be willing and able to travel within the US 30% of the time with potential for OUS travel.

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

$64,500 - $140,800

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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