Biologist-QC Micro-IAPI

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities:

The Biologist-QC-IAPI is responsible for performing microbial methods (MicroSEQ, Endotoxin, TAMC, TYMC, Bacteriophage) and Environmental Monitoring supporting API manufacturing. The biologist completes second person verification 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 requestedAccurately 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 requirementsMay perform holistic review of data for release of data from the laboratoryRecognizes when a deviation from procedures, etc. has occurred and initiates and participates in a Root Cause InvestigationPerforms investigations for deviationsTroubleshoot 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 guidanceDevelop equipment qualification protocols with appropriate guidancePerform routine equipment calibrations or maintenanceComply with and implement safety standardsExecute notification to management when required by procedures or standardsInitiate change controls and deviationsTrain and mentor others. Develop training materialsProficiency with computer systems LIMS, Empower, Excel, etc.Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerationsDemonstrate strong math and documentation skillsDemonstrate strong oral and written communication and interpersonal interaction skills

Additional Information:
Must complete applicable Learning Plan for Biologist -QC-IAPITasks may require repetitive motion and standing for long periods of timeMay be required to work additional hours to cover testing requestOvertime or weekend work maybe required, as necessary

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.

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. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.