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 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$63,000 - $140,800

The Eli Lilly Clinical Diagnostics Laboratory (ELCDL) supports pre-screening, clinical trial, and assay development activities, as well as diagnostic testing to aid in the diagnosis and treatment of patients. Testing personnel in the ELCDL develop, validate, implement, and perform testing to support the overall business strategy and corporate portfolio objectives. These clinical tests may be used in clinical research or as Laboratory Developed Tests (LDT) but might also include In Vitro Diagnostics (IVD) approved by regulatory bodies. Data generated might also be used to support regulatory submissions. 

Are you a Medical Laboratory Scientist (MLS) or Medical Technologist (MT) that is responsible for specimen handling (validation, triaging, storage) and analysis of human biological samples using different types of laboratory testing? Are you operating under the CAP/CLIA quality system and other regulatory standards, as appropriate? Apply today to join the Lilly Team!

Key Responsibilities of Job:

Pre-Analytical:

Determine the acceptability of specimens for testing according to established criteria.Handle specimens and test orders in Laboratory Information System (LIS)/ Laboratory Information Management System (LIMS).As part of a client service team, act as single point of contact for testing status and communication with customers.Provide consultation to clients including assistance with ordering, shipping, and sample questions or turnaround time expectations.Work with lab business partners to ensure the client accounts are set-up in compliance with testing and quality requirements while maintaining the confidentiality of health information on all patients.

Analytical:

Understand the basic nature of ELCDL assays and their technical process.Skillfully perform routine and sophisticated technical procedures according to established protocols.Produces and documents accurate laboratory results which may be subject to regulatory review.Monitor, operate and troubleshoot instrumentation to ensure functionality.Prepare, test and evaluate new reagents or controls.Demonstrate the ability to make technical decisions regarding testing and problem solving.Performs only those high complexity tests authorized by the laboratory director.

Post Analytical:

Report accurate and on time test results.Manage clinical lab data and generate reports.Maintains the confidentiality of health information on all patients.Ensure prompt communication to client on matters related to availability of test results or issues with specimens during receipt or testing.

General:

Must follow laboratory procedures.Demonstrate proficiency and competency.Document all corrective actions when testing deviates from lab established performance specifications.Identify and replenish testing bench supplies as the need arises.Perform and document preventive maintenance and quality control procedures.Maintenance and QC of laboratory reagents and equipment.Maintain inventories of reagents and lab supplies.Maintain a safe work environment and wear appropriate personal protective equipment.Other duties and projects as assigned.Performs well in a team, open to sharing and receiving knowledge and skills, as the need arises.

Application of regulatory requirements:

With supervision, responsible for understanding and applying regulations as they relate to analytical method development, validation, and execution.Conduct and document all laboratory procedures according to appropriate regulations.Exhibit behavior that supports and promotes all appropriate Lilly and regulatory procedures and CAP/CLIA guidelines.Effectively apply specialized diagnostics knowledge and in depth understanding of applicable internal, external, and regulatory requirements/expectations (MQA, CSQ, FDA, ICH, Privacy, Diagnostics, CLIA) for management of samples. 

Technical process application and improvement:

Develop and apply expertise and knowledge of instrument operation and theory.

Minimum Qualification Requirements: 

Bachelor’s degree in a Core Science or Statistics related degree from an accredited institution3+ years of laboratory experienceASCP/AMT certifiedMeet one of the CLIA requirements for high complexity testing personnel under 42 CFR 493.1489.

Additional Skills/Preferences:

MT/MLS preferred.Ability to inspire change and implement process improvement.Ability to thrive in gray space and have a solid understanding of testing and quality principles--not just the written guidance.Strong interpersonal and team related skills required.Experience with various assay platforms and computer software applications including LIS systems.Hands on laboratory experience in Immunoassay and Molecular preferred.Experience in data analysis or statistics and associated tools preferred.Knowledgeable in CAP/CLIA and CLSI guidelines.Knowledge of homebrew assays and Laboratory Developed Tests is helpful.

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 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.

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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