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:

Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do. This position is within a newly created Center of Excellence for bioanalytical technologies supporting commercialization and testing of products globally.

The Bioanalytical Technology Steward provides technical support for technologies including cell-based bioassays, immunoassays, and qPCR methods and oversees the management of critical reagents globally, as needed. The Bioanalytical Technology Steward reviews, interprets, and releases batch results for the laboratory. When appropriately qualified, performs the holistic review of analytical results associated with a batch and issues the Certificate of Testing, when required. Performs non-routine lab work in support of resolution of these technical issues, sample characterization, or method development, transfers and validation.

The Bioanalytical Technology Steward utilizes their technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and complete thorough investigations of aberrant data. Outcomes of these activities including results, conclusions, and action plans are owned by the Bioanalytical Technology Steward and may be published in regulatory and/or technical documents. The Bioanalytical Technology Steward works well cross functionally to lead and influence the technical agenda.

Responsibilities:

Sample Analysis and Reporting

• Perform analytical test methods or support activities as per procedures or protocols. Use technical knowledge in the review and interpretation of data for conformances to procedures, standards and protocols and/or real-time recognition of aberrant data and results.
• Verify analytical data of other analysts within the lab as requested.
• May perform holistic review of data for release of data from the laboratory.

Problem Solving

• May participate in a Root Cause Investigations, as needed as quality control technical resource.
• Troubleshoot equipment and methods as required.

Continuous Improvement Initiatives

• Share technical information and authors regulatory and/or technical reports and memos.
• Research and recommend new technologies.

Method Stewardship/Benchwork

• Method development and validation/remediation.
• May monitor method and process performance.
• Bioanalytical critical reagent maintenance and characterization testing.

Lab Operations

• Write protocols for non-routine testing, method transfers and/or validations.
• May perform equipment calibrations or maintenance.
• Execute notification to management when required by procedures or standards.
• Train and mentor others.
• Develop training materials.

Basic Requirements:

• Bachelor's degree (4-year College) in a science field related to the lab (e.g., chemistry, micro or biology)
• Minimum 7+ years of relevant experience in a GMP lab

Additional Preferences:

• Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations.
• Proficiency with computer systems.
• Understanding of statistical tools and analysis.
• Demonstrate strong problem solving and analytical thinking skills.
• Demonstrate strong oral, written communication and interpersonal interaction skills.
• Strong attention to detail and ability to organize/prioritize multiple tasks.
• 7+ Years of Quality Control or Analytical Development Experience with proteins or peptides.
• Experience in the development and validation of bioanalytical technologies.
• Experience and knowledge of cGMP requirements in large molecule drug substance manufacturing.

Additional Information:

• Known Allergens in area
• Work in a dynamic and fast paced environment

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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