E&L Group Leader - GMP CRO, Analytical Development

RXinsider LTD.; Morrisville, Northern (NC, KY); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K retirement plan

Job summary

Pace is seeking a Group Leader/Supervisor for Extractables & Leachables (E&L) within a GMP CRO environment in the United States. You will oversee the E&L team, manage projects, and ensure quality deliverables for client work across regulatory frameworks.

The role requires leadership, technical expertise with LC-MS/GC-MS, and a commitment to inspection readiness. Join Pace to drive operational excellence and client satisfaction in a fast-paced analytical development setting.

Qualifications

• Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 5 years of experience in a pharmaceutical, biopharmaceutical, CRO, or GMP-regulated analytical laboratory.
• Previous leadership or supervisory experience preferred.
• Strong organizational, communication, problem-solving, and people leadership skills.
• Ability to manage multiple priorities in a fast-paced, client-focused environment.

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.
• Serve as a technical and operational resource for E&L projects and client interactions.
• Review and approve protocols, reports, data packages, investigations, and laboratory documentation.
• Ensure compliance with GMP regulations, company quality systems, and data integrity requirements.
• Partner with Quality Assurance and cross-functional teams to maintain inspection readiness.
• Drive continuous improvement initiatives to enhance laboratory efficiency, quality, and productivity.
• Support business growth through technical expertise, client engagement, and team development.

Skills

Leadership

Communication

Problem solving

People leadership

Prioritization

Education

Bachelor's degree in Chemistry or related field

Advanced degree preferred

Tools

LC-MS

GC-MS

Job description

Pace is seeking a Group Leader/Supervisor for Extractables & Leachables (E&L) within a GMP CRO environment in the United States. You will oversee the E&L team, manage projects, and ensure quality deliverables for client work across regulatory frameworks.

The role requires leadership, technical expertise with LC-MS/GC-MS, and a commitment to inspection readiness. Join Pace to drive operational excellence and client satisfaction in a fast-paced analytical development setting.