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.
Responsibilities:
- The Sr. Principal Associate Lab Informatics - LabVantage LIMS/LES Program 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 work with LIMS/LES such as other manufacturing and automation systems.
- The Sr. Principal Associate Lab Informatics - LabVantage LIMS/LES Program is responsible for business processes owned, delivered, 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 LabVantage application including the reporting, management, and resolution of support issues.
- Coaching and mentoring of system users, sharing key learning and standard processes 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
- Bachelors Degree in STEM field (Science, Technology, Engineering, Mathematics), preference in Chemistry, Biology, Chemical Engineering, or Pharmacy.
- 5+ years of laboratory experience.
Additional Skills
- Experience working in/with GMP laboratories.
- 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 20-30% 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 4 days per month. We believe in providing a balanced work environment that supports both collaboration and individual productivity.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. We provide accommodation for application process as needed. Lilly is an EEO Employer.
