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.
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.
Purpose:
The Clinical Diagnostics Laboratory (CDL) supports clinical trial assay development and sample testing. Medical Technologists in the CDL develop, validate, and implement assays, as well as perform testing to support the overall business strategy and corporate portfolio objectives. Assays include both Laboratory Developed Tests (LDT) In Vitro Diagnostics (IVD) approved by regulatory bodies. Data generated is used to support patient screening and enrollment into clinical trials and may be included in regulatory submissions.
The Scientist - Medical Technologist role in the CDL performs duties in compliance with the CAP/CLIA quality system and other regulatory standards, as appropriate.
Primary Responsibilities:
Pre-Analytical:
Determine the acceptability of specimens for testing according to established criteria.
Build test batches and accession using the CDL Laboratory Information Management System (LIMS).
Analytical:
Produces and documents accurate laboratory results for patient management within clinical trials.
Perform routine and sophisticated technical procedures according to Standard Operating Procedures (SOP).
Post Analytical:
Report accurate and on time test results to meet clinical trial team deadlines.
Manage clinical lab data and generate reports.
Maintains the confidentiality of health information on all patients.
General:
Monitor, operate and troubleshoot instrumentation to ensure functionality.
Demonstrate the ability to make technical decisions regarding testing and problem solving.
Prepare, test and evaluate new reagents or controls.
Identify and replenish testing bench supplies as required.
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.
Application of regulatory requirements:
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.
Maintain Medical Technologist certifications through continuing education and laboratory competencies.
Technical process application and improvement:
Develop and apply expertise and knowledge of instrument operation and theory.
Minimum Requirements:
ASCP/AMT certified
Bachelor's degree in a chemical, biological, or clinical laboratory medical technology from an accredited institution
5+ years of laboratory experience
Bachelor's degree holders in a chemical, biological or clinical discipline may be considered provided CLIA requirements for high complexity laboratory testing personnel are met.
This position requires visual color discrimination. In order to meet laboratory certification requirements, persons who are assigned tasks requiring visual discrimination must first pass a visual color discrimination evaluation. Individuals who cannot pass this evaluation may not perform task, but may still hold this position as long as other qualified employees are reasonably available to perform this task as needed.
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
Additional Skills/Preferences:
Meet CLIA requirements for high complexity testing personnel.
Must be willing to work outside of normal business hours depending on testing volumes and study needs.
MT/MLS preferred.
Ability to inspire change and implement process improvement.
Ability to thrive in grey space and have a solid understanding of quality principles-not just the written guidance.
Strong interpersonal and team related skills required.
Experience with various assay platforms and computer software applications including LIMS.
Bench level experience in Immunoassay and Molecular preferred
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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $182,600
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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