Hybrid BioServices Study Lead: GLP & LC-MS Oversight

IQVIA LLC; 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 across bioanalytical projects. You will partner with Project Management, Medical Writing, Quality Control, and Quality Assurance to meet scientific, regulatory, and scheduling needs.

The role requires advanced LC-MS or immunoassay experience, GLP laboratory expertise, and strong collaboration skills.

Qualifications

• Bachelor's degree in a scientific field is required.
• 3 years' related experience in a GLP laboratory environment.
• Knowledge of liquid chromatography combined with mass spectrometry, or in vitro and immunoassay techniques.
• Experience with sample extraction, assay 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 escape 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

LC-MS knowledge

Immunoassay techniques

Sample extraction

Assay development

Assay validation

Collaboration

Attention to detail

Written communication

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 across bioanalytical projects. You will partner with Project Management, Medical Writing, Quality Control, and Quality Assurance to meet scientific, regulatory, and scheduling needs.

The role requires advanced LC-MS or immunoassay experience, GLP laboratory expertise, and strong collaboration skills.