Senior Manager

2 weeks ago


Indiana, Pennsylvania, United States Eli Lilly Full time
Senior Manager - Laboratory Informatics
At Eli Lilly, we combine compassion with innovation to enhance the quality of life for individuals globally. As a prominent leader in healthcare, our headquarters is located in Indianapolis, Indiana.

Our global workforce is dedicated to discovering and delivering transformative medications to those in need, advancing the understanding and management of diseases, and contributing to our communities through philanthropy and volunteer initiatives.

We are committed to excellence in our work and prioritize people. We seek individuals who are passionate about improving lives worldwide.

The Bioproduct Research and Development (BRD) division is a forward-thinking entity within Eli Lilly and Company.

BRD plays a crucial role in the development of parenteral biologics drug substances and products, including chemically synthesized biomolecule drug products, from pre-clinical stages to commercialization.

Our vibrant department consists of molecular and cell biologists, purification and process engineers, pharmaceutical scientists, analytical chemists, and engineers.

We aim to identify, develop, and implement pioneering technologies to maximize benefits for our patients.

BRD fulfills these responsibilities by acknowledging that diverse talents and cultures are essential for delivering the next generation of life-altering medicines to patients.

BRD Analytical is a versatile, cross-functionally integrated, and capability-driven team within BRD, dedicated to providing cutting-edge measurement sciences to enhance product and process understanding, leading to optimized control strategies.

Our mission encompasses elucidating molecular-level understanding, defining critical quality attributes, integrating CMC knowledge, establishing new platforms and technologies, and achieving regulatory approval to commercialize life-changing medicines.


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


The team is responsible for the validation and deployment of new instrument systems, as well as managing upgrades, administration, and troubleshooting for existing instrument software in analytical laboratories.


Key Responsibilities:
- Validate and support standalone instrument systems.
- Assist in the creation and maintenance of critical documents and change controls.
- Influence the design and development of new informatics tools.
- Manage access rosters and provide software support for multiple lab instrument systems.
- Conduct periodic reviews of access rosters and system audit trails.
- Collaborate with instrument software vendors to resolve software configuration issues.
- Work with various IT groups, vendors, and laboratory personnel to validate and maintain instrument systems software throughout the entire system lifecycle.
- Ensure proper backup of identified instrument data.
- Adhere to local standards for documentation practices and record retention.
- Reference and update guidance documents as necessary.
- Generate process metrics as required.
- Respond to inquiries regarding lab instrument validation and support processes.
- Notify lab leaders and escalate issues if data integrity processes are not adhered to.


Informatics Tools Development and Business Operations Support:
- Create templates to capture information from scientists using Excel, PowerBI, and develop SharePoint sites.
- Validate and maintain tools identified as having GxP impact.
- Perform data integrity tasks.
- Create and manage change controls using Trackwise software.
- Construct intuitive dashboards for scientists to quickly retrieve and visualize high-frequency/high-impact data.
- Summarize scientific data from multiple reports into concise documents or reports using Microsoft Word, Excel, or electronic notebooks.
- Compile and track data for control charting.
- Conduct data integrity reviews for scientific reports and tables.
- Develop MS Office templates to support change control documentation.
- Create data integration templates.


Minimum Qualifications:
- Bachelor's or master's degree in science, information technology, or a related field with a minimum of 3 years of industrial experience in a regulated environment.
- Familiarity with laboratory techniques and analytical testing.
- Experience using and/or supporting lab instrument applications for standalone instruments such as plate readers, KF ovens, and spectrophotometers; system administration experience is preferred but not mandatory.
- Understanding of computer system validation processes.
- Proficiency with Microsoft products and platforms, including Excel, Word, SharePoint, OneNote, PowerBI, and PowerApps.
- Ability to summarize technical information, including data, in written format.
- Strong communication, coordination, and project management skills, as the candidate will collaborate directly with personnel from lab, IT, and QA areas.
- Excellent organizational skills to manage multiple tasks daily and ensure timely completion.



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