Chemist – QC – IAPI (eSystems Automation)

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description:

The Chemist – QC – IAPI (eSystems Automation) provides electronic automation system technical and compliance support for Indianapolis API Operations QC.  The Chemist – QC – IAPI is responsible for design and maintenance of automation systems, execution of laboratory CSV initiatives, analytical method management, eLN templates/scripting, and QC infrastructure requests. This individual will provide support for related QC activities (i.e.: support, new equipment installation, data integrity, agency and internal inspections, system upgrades, change management, observation/deviation management, reviews, and related global initiatives).

Responsibilities:

• Provide oversight, development, ongoing support and maintenance of QC automation equipment (ie: Hamilton, Tecan, and Eppendorf liquid handlers and associated robotic hardware)
• Provide support for the implementation and maintenance of electronic notebooks
• SME for laboratory computer system audit activities, validation and periodic reviews
• Interacts effectively with business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements
• Understands direction of technology and its impact on laboratory business processes, quality systems and the QC organization
• Implements programs/processes which improve overall compliance and quality in the QC Laboratories
• Train and Mentor analysts through formal process/program
• Assess, review and author change controls and deviations for eSystems and QC instrumentation
• Utilize technical skills to lead or perform in-depth investigations affecting data integrity.  Draws conclusions and performs root cause analysis investigations and recommends solution to prevent reoccurrence
• Support laboratory infrastructure and act as a liaison between QC and the IT organization (e.g., instrument interfacing, data archiving, technology infrastructure and data parsing)
• Evaluate new laboratory technologies for impact to other QC systems portfolio and provide direction in qualification of new equipment technologies
• Improve laboratory quality systems; develop content, review and approve SOPs and training as necessary
• Influences business areas’ understanding of their own business processes, identifies new opportunities, challenges the status quo, and helps develop recommendation for using ESystems Automation to improve business process productivity

Basic Requirements:

• Bachelor’s Degree (4 year College) in a scientific field related to the lab (e.g., Chemistry, Microbiology or Biology) or 4-7 years of relevant experience in a GMP laboratory
• 3+ Years of lab experience, QC preferred

Additional Preferences:

• Experience with a focus on electronic lab notebooks and instrument infrastructure.
• Experience with laboratory automation equipment such as Hamilton, Tecan, or Eppendorf liquid handlers.
• Proficiency with computer systems
• Demonstrate strong oral, written communication and interpersonal interaction skills
• Deep understanding of laboratory quality systems and their dependencies (e.g., TrackWise, SmartLab, Darwin, Empower and other E3B laboratory systems)

Additional Information:

• Must complete Learning Plan for an Chemist – QC – IAPI (eSystems Automation)
• May be required to provide off hours support coverage

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 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). 

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