Technical Operations Associate/Sr. Associate

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.

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. For more information, visit www.avidrp.com.

Position Overview:

The Technical Operations Associate is responsible for troubleshooting production issues with 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
• 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 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:

• Associate's degree in a relevant field, or higher degree such as bachelor's or Master's degree.

Additional Skills/Preferences:

• Bachelor's degree in scientific field is a plus
• Advanced degree preferred in a scientific or technical area
• 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 and worldwide 30% of the time
• Lilly currently anticipates that the base salary for this position could range from between $61,500 to $132,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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.
• As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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