Bioanalytical Study Lead — GLP, Hybrid

IQVIA; Indianapolis (IN); Hybrid; USD 64,000 - 134,000; Full time

Job summary

IQVIA Laboratories in Indianapolis, IN seeks an Associate BioServices Study Lead - Hybrid to provide scientific oversight through bioanalytical projects, partnering with PM, Medical Writing, QC, QA to meet regulatory and scheduling requirements.

You will lead method development and validation, supervise GLP studies, review reports, manage project status, and maintain client communications while adhering to GCP/GCP standards.

Qualifications

• Bachelor’s Degree Scientific field required
• 3 years’ related experience. Equivalent combination of education, training and experience in GLP laboratory environment.
• Understanding of liquid chromatography combined with mass spectrometry, or in vitro and immunoassay techniques
• Experience with sample extraction, routine laboratory procedures, assay method development, and assay validation

Responsibilities

• Provide scientific oversight for method development, method validation, and sample analysis projects
• Serve as Principal Investigator for GLP studies
• Prepare validation and sample analysis plans, approve experimental designs, and review data for regulatory compliance and scientific quality
• Review validation and bioanalytical reports for completeness and address findings from Quality Control and Quality Assurance reviews
• Monitor assigned projects, communicate status updates, and elevate schedule risks to management
• Investigate failed runs, coordinate method troubleshooting, assemble technical resources, and document investigation findings
• Maintain communication with customers, resolve sample discrepancies, coordinate customer visits, and support quote preparation
• Ensure projects are archived in accordance with IQVIA SOPs and comply with applicable Good Clinical Practice and Good Laboratory Practice standards

Skills

GLP Laboratory Experience

LC-MS Understanding

Sample Extraction

Method Development

Communication Skills

Education

Bachelor’s Degree in Scientific Field

Job description

IQVIA Laboratories in Indianapolis, IN seeks an Associate BioServices Study Lead - Hybrid to provide scientific oversight through bioanalytical projects, partnering with PM, Medical Writing, QC, QA to meet regulatory and scheduling requirements.

You will lead method development and validation, supervise GLP studies, review reports, manage project status, and maintain client communications while adhering to GCP/GCP standards.