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
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
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
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 ( LillyRecruitingCompliance@lists.lilly.com ) 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).