Job Description

R-92796

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.

Organization Overview: 

The Laboratory for Experimental Medicine (LEM) Clinical Analysis team is a diverse and dedicated group responsible for the validation and implementation of novel assays for immunogenicity assessment and biomarker studies for clinical programs.  

Responsibilities:

The scientist will work closely with members within and outside LEM in a highly collaborative environment and support the close partnership with interdisciplinary teams.  The scientist will support assay validation and clinical testing for immunogenicity and biomarker studies to support the clinical development new molecular entities.

Responsibilities will include:

• Lead and manage assay transfer, assay validation, assay troubleshooting, and clinical testing, ensuring timelines are met and updates on data deliverables and assay performance are communicated to LEM project leaders, clinical teams, and other stakeholders.
• Review and/or approve documents, procedures, and SOP related to assay method, validation plan, validation report, sample analysis plan, and sample analysis report.

• Develop and implement laboratory protocols, quality control measures, and risk mitigation strategies to maintain compliance with Lilly policies, local and international regulations, and regulatory guidelines.
• Lead the revision of current procedures with new pertinent regulatory expectations identified through discussions with Quality, Regulatory, IT, and TPO partners, documented audit findings, and information generated from scientific and/or regulatory conferences.
• Maintain proper documentation to ensure the validation/study is audit-ready at all times and support regulatory inspections as required.

• Evaluate, develop, and implement new or improved ways to manage and standardize scientific data and reports to achieve increased efficiency and quality of the work.
• Coach and train new analysts in the group on documentation and scientific skills related to LEM immunogenicity and biomarker assay validation and sample analysis.
• Ensure proper inventory management and maintain lab equipment and reagents.
• Perform essential laboratory tasks, including pipetting, weighing, buffer preparation, and working with laboratory automation systems, as needed.
• Validate immunogenicity and biomarker assays and perform analysis of clinical samples following the most current practices and SOPs in use, as needed.

Basic Requirements: 

• Bachelor’s degree or Master’s degree in biology or a related discipline with 3+ years of industry experience.

Additional Skills/Preferences:

• Experience with immunogenicity and biomarker assay validation, troubleshooting, and clinical sample analysis.
• Experience with validated LIMS systems, for instance, Watson, for assay validation and sample analysis.
• Good understanding of relevant regulatory guidance on immunogenicity and bioanalysis.
• Experience working in a regulated (for example, GLP, GCP, Good Manufacturing Practice [GMP], CAP, and Clinical Laboratory Improvement Amendments [CLIA]) environment.
• Excellent problem-solving ability.
• Proven organizational skills and strong interpersonal skills.
• Excellent oral and written communication skills.
• Proven Microsoft Word, Excel, Teams, SharePoint, and PowerPoint skills.
• Ability to manage multiple projects and meet timelines.
• Knowledge and experience with immunogenicity assessment and assay development, for instance, affinity capture elution assay, affinity capture elution bridging assay, and cell-based neutralizing antibody assay
• Supervisory experience with lab analysts
• Automation of immunogenicity and biomarker assays and sample analysis
• Familiarity with the design and conduct of clinical trials.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is$64,500 – $182,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.