Associate Director – Routine Lab Operations and Sample Management

Industry:

Company: Eli Lilly and Company

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
$118,500 – $173,800

Eli Lilly Clinical Diagnostics Laboratory

Associate Director, Routine Laboratory Operations and Sample Management

Purpose of the Job:

The Eli Lilly Clinical Diagnostics Laboratory (ELCDL is a wholly-owned subsidiary of Eli Lilly and Co. ELCDL offers clinical diagnostic testing and supports portfolio-driven assay development to aid in the diagnosis and treatment of patients with chronic and rare diseases. Scientists in the ELCDL develop, validate, implement, and perform testing to support the overall lab business strategy as well as Eli Lilly corporate portfolio objectives. Tests offered by ELCDL for direct patient care are largely Laboratory Developed Tests (LDTs) but might also include In Vitro Diagnostics (IVD) approved by regulatory bodies. The lab also actively engages in clinical utility evidence-generation and may produce data for support of regulatory diagnostic submissions.

The Associate Director of Routine Laboratory Operations and Sample Management role includes oversight of day-to-day operations within the clinical lab including sample management (SM), implementation and technical representation of the Laboratory Information System (LIS) and/or Laboratory Information Management System (LIMS), client services related to sample testing, and management of routine analytical testing operations. As SM Area Lead, the Associate Director will have ownership of sample life cycle and result data, including specimen receipt, specimen accessioning, testing order verification, test result reporting, and specimen disposal. As a Routine Operations lead, the Associate Director will help oversee routine laboratory testing, under the auspices of the General Laboratory Supervisor (GLS) and Laboratory Medical Director (LMD).

Key Responsibilities:

• Design and management of sample and data processes and workflows
• Oversight of LIS/LIMS to ensure functional and compliant lab test ordering and reporting operations
• Basic lab operations management including oversight of routine lab testing
• Oversight of client services related to commercial sample testing
• Responsibility for adherence to applicable Quality and Regulatory bodies for sample and data management and routine lab testing
• Other laboratory management or oversight duties which may arise when needed, e.g. temporary cross-coverage for the lab Development or Business teams, as determined by the GLS or LMD.

Specific duties:

Sample and data management

• Oversees and designs routine procedures and workflows for accessioning, allotment, and storage of samples received in the lab for commercial, clinical trial, or research testing.
• Oversees and designs procedures and workflows for test result data for commercial, clinical trial, and research testing.
• Oversees and designs processes related to client services related to in-house samples. Manages the Client Services Team for these samples.
• Responsible for writing Standard Operating Procedures related to sample and data management, working closely with lab Quality representatives.
• Responsible for following applicable standards including CAP/CLIA and those established by parent company, for sample and data processes.
• Responsible for data integrity for all sample types. Ensures commercial patient reports are accurate, formatted correctly and aligned with applicable regulatory standards/requirements. Ensures clinical trial or research testing results meet deliverable needs/specifications and any regulatory agency requirements.
• Responsible for troubleshooting and managing problems that arise in the handling or storage of samples or test results data, such as mislabeled or discrepant samples, missing test orders, and problems adhering to research data timelines.
• Interfaces well with lab Business, Quality, and Development teams to ensure smooth and uninterrupted testing operations that adhere to applicable regulatory requirements and safety guidelines.
• Works closely with Lilly IT to manage LIS/LIMS for smooth and compliant laboratory operations. Oversees regular LIS/LIMS software updates and modifications from the laboratory side.
• Manages personnel in the Sample Management team.

Routine lab operations management

• Understands and implements requirements for routine lab analytical operations and safety in the CAP/CLIA environment, for direct patient care and clinical trial or study support.
• Oversees supplies and reagents necessary for routine operations.
• Helps to manage validation of new assays from the analytical side.
• With guidance from the GLS and LMD, oversees and manages performance of routine quality measures in the lab such as Key Performance Indicators (KPIs), lab equipment notebook reviews, review of instrument qualifications, review of proficiency and competency testing, monitoring of QC documentation.
• Responsible for writing analytical SOPs related to routine laboratory testing, while adhering to appropriate regulations and guidelines (CAP/CLIA/FDA).
• Reviews and approves procedure and process documents.

• Manages lab technical personnel including ensuring competency and CE requirements are fulfilled. Oversees personnel curriculum and training requirements and approval.
• Approves appropriate purchases needed for routine lab operations.
• Works with representatives in lab Quality and Safety to ensure highest quality and safety standards in the laboratory.

Minimum Qualification Requirements:

–Bachelor’s degree in a Core Science.

–Certified ASCP or AMT medical technologist (MT/MLS/CLS) with at least 5 years experience working in a CAP/CLIA patient care laboratory, including at least 2 years of supervisory experience in a clinical laboratory.

–Prior experience in oversight of LIMS/LIS functioning in a clinical laboratory is preferred.

–Knowledge of sample management, Laboratory Developed Tests (LDTs), molecular assays, and Immunoassays is preferred.

Key skills:

–Ability to routinely assess for efficiency and implement process improvement when needed.

–Ability to work well in a fast-paced, constantly changing industry environment with often unique and varied data deliverables.

–Ability to work well with other cross-functional team managers in Business, Quality, and Development from within the lab and from the parent company.

–Strong interpersonal and management skills.

–Strong communication skills with the ability to listen with empathy and motivate others through coaching.

Additional Skills/Preferences:

–Six Sigma or process improvement experience.

–Experience working in a high throughput laboratory.

–Data processing or IT skills.

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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