Job Description

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 35,000 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.

Bioproduct Research and Development (BRD) is an innovation-focused organization within Eli Lilly and Company. BRD is involved in key activities for the development of parenteral biologics drug substance and drug products including chemically-synthesized biomolecule drug products from pre-clinical phases through commercialization. Our dynamic department is made up of molecular and cell biologists, purification and process engineers, pharmaceutical scientists, analytical chemists, and engineers. We strive to identify, develop, and apply groundbreaking technologies to deliver maximum benefit to our patients. BRD delivers on these responsibilities by recognizing diverse talent and cultures are vital to bring the next generation of life changing medicines to patients. BRD Analytical is a flexible, cross-functionally integrated, and capabilities driven team within BRD committed to providing state of the art measurement sciences to guide product and process understanding leading to optimized control strategies. Our mission is to elucidate understanding at molecular level, define critical quality attributes, integration of CMC knowledge, establish new platforms and technologies, and achieve regulatory acceptance to commercialize life changing medicines.

The Lab Instrument Informatics and Business Operations Support role provides support to the BRD scientist group, assisting with administrative support, access management and other non-laboratory-based activities that support analytical development, characterization, testing, and documentation.

The team supports validation and deployment of new instrument systems, as well as upgrades, administration and troubleshooting for existing instrument software in analytical labs.

Job responsibilities include validation and support of standalone instrument systems, support in creation/maintenance of critical documents, change controls, and influencing the design and development of new informatics tools.

Lab Instrument System support

• Manage access rosters for and software support for multiple lab instrument systems
• Lead periodic reviews of access rosters, system audit trails
• Work with instrument software vendors to fix software configuration issues
• Work with multiple IT groups, vendors and lab personnel to validate instrument systems software and maintain them through entire system lifecycle.
• Ensure proper back up of identified instrument data
• Follow the local standards for documentation practices and record retention
• Reference and update the guidance documents
• Generate process metrics as required
• Respond to all phone calls, instant messages, and emails regarding lab instrument validation and support process questions
• Notify lab leaders and/or escalate issues if appropriate data integrity processes are not followed

Informatics Tools Development and Business Operations Support

• Create templates to capture information from scientists using Excel, PowerBI, and develop Sharepoint site
• Validate and maintain tools that are identified as having GxP impact
• Data integrity tasks.
• Create and manage change controls using Trackwise software application. Utilize Trackwise or other program to assign tasks to scientists
• Construct useful and intuitive dashboards enabling scientists to retrieve and visualize high frequency/high impact data quickly. Utilize dashboards to monitor progress of tasks and notify scientists of upcoming due dates
• Translate and summarize scientific data from multiple data reports into a summary document or report utilizing Microsoft Word, Microsoft Excel, or an electronic notebook
• Compile and track data for control charting
• Perform data integrity reviews for data contained in scientific reports and tables
• Develop MS Office templates to support change control documentation.
• Develop data integration templates.

Minimum Requirements:

- Bachelors or master's degree in science, information technology or related field with at least 3 years industrial experience in a regulated environment

• A working knowledge of laboratory techniques and analytical testing.
• Experience with using and/or supporting lab instrument applications for standalone instruments like plate readers, KF ovens, spectrophotometers, etc. System administration experience is preferred but not required
• Understanding of computer system validation processes
• Proficiency with existing Microsoft products and platforms, including Excel, Word, Sharepoint, OneNote, PowerBI, Powerapps.
• Ability to summarize technical information, including data, into a written format
• Excellent communication, coordination and project management skills: the candidate will work directly with people from lab, IT and QA areas
• Organizational skills: the candidate will handle multiple tasks daily and track to ensure tasks are completed.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly 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.

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