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Lilly Biologist - Quality Control in Indianapolis, Indiana

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.


The Biologist-QC-IAPI (Indianapolis Active Pharmaceutical Ingredient) is responsible for performing microbial methods (MicroSEQ, Endotoxin, TAMC, TYMC, Bacteriophage) and Environmental Monitoring supporting API manufacturing. The biologist completes second person verification (SPV) as well as participates in laboratory root cause investigations, equipment evaluations and qualification, and some quality system improvement initiatives by executing well-defined protocols and procedures. The biologist works independently and communicates well with peers and customers.

  • Verify (SPV) analytical data of other analysts within the lab as requested

  • Accurately and safely perform analytical test methods or related support activities as per procedures or protocols. Uses technical knowledge in the review and interpretation of data for conformances to procedures, standards, and protocols and/or real-time recognition of aberrant data and results.

  • Perform data entry and reviews own work for accuracy in accordance with laboratory procedures, standards and GMP requirements

  • May perform holistic review of data for release of data from the laboratory

  • Recognizes when a deviation from procedures, etc. has occurred and initiates and participates in a Root Cause Investigation

  • Performs investigations for deviations

  • Troubleshoot equipment and methods as required

Basic Requirements:

  • Bachelor’s degree (4-year College) in a science field related to the lab (e.g., chemistry, micro or biology) or

  • 5 years of demonstrated relevant experience in a GMP (analytical or microbiology) lab

Additional Preferences:

  • Write protocols for non-routine testing or validation with appropriate guidance

  • Develop equipment qualification protocols with appropriate guidance

  • Perform routine equipment calibrations or maintenance

  • Comply with and implement safety standards

  • Execute notification to management when required by procedures or standards

  • Initiate change controls and deviations

  • Train and mentor others. Develop training materials

  • Proficiency with computer systems LIMS, Empower, Excel, etc.

  • Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations

  • Demonstrate strong math and documentation skills

  • Demonstrate strong oral and written communication and interpersonal interaction skills

Additional Information:

  • Must complete applicable Learning Plan for Biologist -QC-IAPI

  • Tasks may require repetitive motion and standing for extended periods of time

  • Additional hours maybe required to cover testing requests

  • Overtime or weekend work required, as necessary

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 ( ) 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.

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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).