E&L Group Leader - GMP CRO Analytics

Pace® Labs; Morrisville (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401K retirement plan (employer match)

Paid time off

Job summary

Pace Labs is seeking a Group Leader/Supervisor for Extractables & Leachables (E&L) within a GMP CRO environment. You will lead a team of scientists, oversee study design, data review, and client communications while ensuring regulatory compliance and data integrity.

The role emphasizes leadership, project coordination, and technical expertise in E&L studies, LC-MS/GC-MS, and method development, with a focus on delivering high-quality results to clients.

Qualifications

• Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related discipline.
• Advanced degree preferred.
• Minimum 5 years of experience in a pharmaceutical, biopharmaceutical, CRO, or GMP-regulated analytical lab.

Responsibilities

• Lead, coach, and develop a team of scientists and analysts performing E&L studies.
• Manage project timelines, laboratory resources, and workload prioritization to meet client commitments.
• Review and approve protocols, reports, data packages, investigations, and laboratory documentation.
• Ensure GMP compliance, data integrity, and quality systems.
• Partner with QA and cross-functional teams to maintain inspection readiness.
• Drive continuous improvement to enhance laboratory efficiency and productivity.

Skills

People leadership

Project management

Communication

Problem-solving

Education

Bachelor's degree in Chemistry or related

Advanced degree preferred

Tools

LC-MS

GC-MS

Analytical platforms

Job description

Pace Labs is seeking a Group Leader/Supervisor for Extractables & Leachables (E&L) within a GMP CRO environment. You will lead a team of scientists, oversee study design, data review, and client communications while ensuring regulatory compliance and data integrity.

The role emphasizes leadership, project coordination, and technical expertise in E&L studies, LC-MS/GC-MS, and method development, with a focus on delivering high-quality results to clients.