Scientist – Medical Technologist

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 po