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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.

Purpose:

The CDL implements clinical and translational biomarkers to support Companion Diagnostic development.  The Sample Management Associate is responsible for sample integrity and processing throughout the sample lifecycle in CDL, supporting clinical trial assay development and sample testing, and proactively supporting multiple workstreams while appropriately prioritizing work and meeting timelines.  

Primary Responsibilities:

Sample Management

• Manage all aspects of sample lifecycle. Includes sample check-in, quality checks, issue resolution, sample distribution, sample tracking, sample destruction and data reporting.
• Assist in the management of external biomarker work, including managing shipments to vendor laboratories, generation of purchase orders, and managing samples that return to Lilly.

Project Management

• Escalates issues as warranted to upper management. 
• Provides leadership to sample management team resolving issues that are out of scope of existing SOPs.
• Collaborates within the CDL Group, cross-functional groups, and with external customers.
• Influences day-to-day oversight of the sample management staff, including flexible management of the changing priorities of sample and data.

Communication and Information Management

• Maintain documents in accordance with applicable regulations; prepare and present data.
• Utilization of computer software such as Excel, Word, Power Point or other data visualization tools to organize and analyze data.

Data Management

• Perform data QC and / or data transfers following approved process.
• Demonstrate proficiency in utilizing Sample Management LIMS

Application of Regulatory Requirements

• Responsible for understanding and applying regulations as they relate to sample lifecycle execution.
• Document and conduct procedures according to appropriate regulations.
• Exhibit behavior that supports and promotes CAP/CLIA and GCP and adheres to all appropriate Lilly and regulatory procedures and guidelines.

Research Related to Special Biomarkers

• Prepare clinical specimens for sample analysis, tissue microtomy and staining, and high-resolution imaging.
• Assist in the development and characterization of clinical biomarker assays to support clinical drug development, including pre-analytical sample handling and post analytical data management and quality control.
• Assist scientists who partner with external vendors to support diagnostic development.
• Perform regular maintenance and quality checks on instruments and equipment as assigned.

Technical Writing Skills

• Assist in the development of methods, reports, SOPs and other documentation.
• Present data to internal CDL staff.
• Contribute to reports, regulatory documents, manuscripts, posters, etc.

Technical Process Application and Improvement

• Develop and utilize expertise and knowledge of instrument operation and theory.

Minimum Qualification Requirements:

• 3 years of experience in sample handling and LIMS utilization in CLIA/CAP regulated environments
• Bachelor’s degree in a life sciences area
• Ability to be on site at LCC 5 days/week and periodic work outside of normal business hours
• Organized and attentive to details
• 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.

Other Information/Additional Preferences:

• Strong self-management skills
• Excellent problem-solving skills; ability to work cross-functionally between laboratory and key partners to drive issue resolution
• Project and Time Management skills; ability to handle multiple projects and meet timelines established by teams
• General laboratory skills, including experience managing tissue samples
• Experience with basic computer software applications, including MS Excel
• Working knowledge of CAP / CLIA regulations
• Clinical biomarker development and / or Laboratory Developed Test (LTD) experience preferred, not required

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

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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