Bioanalytical Study Lead (GLP, Hybrid)

IQVIA Argentina; 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 for bioanalytical projects. You will collaborate with Project Management, Medical Writing, Quality Control, and QA to ensure regulatory and scheduling requirements are met.

Responsibilities include leading GLP studies, preparing validation plans, reviewing reports, and coordinating investigations. Strong communication with clients and cross-functional teams is essential.

Qualifications

• Bachelor's degree required in a scientific field.
• Minimum 3 years of GLP laboratory experience.
• Knowledge of liquid chromatography coupled with mass spectrometry and immunoassay techniques.

Responsibilities

• Provide scientific oversight for method development, validation, and sample analysis projects.
• Serve as Principal Investigator for GLP studies.
• Prepare validation and sample analysis plans and review data for regulatory compliance.
• Review validation and bioanalytical reports for completeness and address QA findings.
• Monitor project status and communicate risks to management.
• Investigate failed runs and coordinate troubleshooting and documentation.
• Maintain customer communications, resolve discrepancies, and support quote preparation.
• Ensure archival of projects per IQVIA SOPs and GLP/GCP standards.

Skills

GLP laboratory experience

Chromatography (LC-MS)

Method development oversight

Education

Bachelor's Degree in Scientific field

Tools

LC-MS instrumentation

Job description

IQVIA Laboratories in Indianapolis, IN seeks an Associate BioServices Study Lead - Hybrid to provide scientific oversight for bioanalytical projects. You will collaborate with Project Management, Medical Writing, Quality Control, and QA to ensure regulatory and scheduling requirements are met.

Responsibilities include leading GLP studies, preparing validation plans, reviewing reports, and coordinating investigations. Strong communication with clients and cross-functional teams is essential.