Scientist - LEM

Eli Lilly and Company • Indianapolis, IN

4d • Onsite

About The Position

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. 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 of new molecular entities.

Requirements

• Bachelor’s degree in biology or a related discipline with 3+ years of industry experience.
• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• Master’s degree
• 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.

Responsibilities

• 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, as needed.
• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior