Sr. Principal Associate – Lab Informatics, LUNA Program - LIMS/LES

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

Company Overview

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 39,000 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.

Responsibilities:

• The Sr. Principal Associate – Lab Informatics -LUNA Program LIMS/LES is part of a team of informatics professionals who work closely with Tech@Lilly to identify, develop, validate, deploy, maintain, and defend globally owned, GMP compliant, informatics applications throughout their lifecycle. They represent the needs and interest of the business areas they support, and act as their voice and advocate.

• This position will focus on being the subject matter expert for LIMS/LES Systems by championing standardization of business processes, workflows, master data, and procedures globally to enable manufacturing sites and quality control labs to deliver world class performance. The candidate must consider the impacts of additional business processes that interface with LIMS/LES such as other manufacturing and automation systems.

• The Sr. Principal Associate – Lab Informatics -LUNA Program LIMS/LES is responsible for business processes owned, executed, and maintained by the Quality Control function, including Test Execution, Data Documentation, Instrument Data Collection, Lab Inventory/Consumable Management, Equipment/Instrument Management, Lab Data Integrity, Data Review, and associated Test Automation and/or Master Data Management.

Business Requirements and Processes

• Collaborate with business SMEs and stakeholders to define, develop and refine new business processes that promote the effective use of current and NextGen LIMS/LES applications.
• Develop and document Standard Operating Procedures (SOPs) for the application.
• Identify areas for improvement, propose, network, and implement
• potential solutions.
• Support deployment activities by guiding the sites on the “to be” processes on the NexGen solutions.
• Partner with third party application experts to find solutions to set up processes in the system or resolve issues.
• Advocate for users and stakeholders across the organization throughout requirements gathering and refinement of future release schedules.

Develop, Validate, and Implement systems and solutions

• Identifying, refining, and standardizing global business requirements and business specific system configuration items, providing business input and guidance for system design decisions.
• Develop testing protocols and associated test scripts, authoring/editing validation deliverables, and execution/review of business-related validation test scripts.
• Participate in the execution of User Acceptance Testing (UAT) to ensure the application meets business requirements and quality standards.
• Document rational of business decisions to enable efficient progress, review, and historical reference.

Master Data

• Knowledge in LIMS/LES master data and collaborate with the Global Data Stewards in the architecture of method built.
• Experienced in the master data elements related with instrument connectivity

Training

• Partner with global training representatives and third-party professional services teams to develop and maintain training materials.
• Work closely with global and local training professionals and third-party providers throughout this process to ensure effective delivery of the training regimen to site personnel.

Support Team Participation and Issue Resolution:

• Provide ongoing support for Project LUNA LIMS/LES including the reporting, management, and resolution of support issues.
• Coaching and mentoring of system users, sharing key learning and best practices to the global LabVantage community to increase their system knowledge, and the identification of transferrable work processes between sites.

Inspection Support:

• The candidate will be part of the team that will provide answers to questions from inspections, audits, and other formal and informal assessments that impact globally owned applications and their associated workflows.

Basic Requirements

Education

• Minimum of Bachelor’s Degree or equivalent experience in Chemistry, Biology, Chemical Engineering, Pharmacy, or a related field.
• 5+ years of laboratory experience
• Experience working in/with GMP laboratories

Skills

• Strong scientific background
• Clear understanding of quality laboratory issues and activities
• Experience in defining and improving business processes
• Knowledge of cGMP and quality systems
• Proficient in quality documentation, control processes, and data integrity principles.
• Proven work with computer systems and their adaptability to existing business processes.
• Extensive knowledge of analytical methods, laboratory documentation and control processes.
• Knowledge of product release processes.
• Experience in defining and improving business processes

Additional Information

This position will require occasional travel to manufacturing sites, development laboratories, and application vendors. Individual must be willing to visit laboratory and manufacturing sites involving unique PPE and/or gowning requirements.

This role is primarily on-site, with the flexibility to work from home two days a week. We believe in providing a balanced work environment that supports both collaboration and individual productivity.

Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.

Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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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