Group Leader / Supervisor, Extractable & Leachable (E&L)

Pace® Analytical Services•Morrisville, NC

6d•Onsite

About The Position

We are seeking an experienced Group Leader/Supervisor to lead our Extractables & Leachables (E&L) team within a fast-paced, GMP-regulated Contract Research Organization (CRO). This role is responsible for overseeing daily laboratory operations, managing and developing scientific staff, ensuring high-quality technical deliverables, and supporting client projects from initiation through completion. The successful candidate will combine strong technical expertise with effective leadership to drive operational excellence, regulatory compliance, and customer satisfaction.

Requirements

Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred.
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.

Nice To Haves

Experience with Extractables & Leachables (E&L) study design, execution, and data interpretation.
Proficiency with LC-MS and GC-MS, analytical platforms.
Knowledge of GMP regulations, data integrity principles, and pharmaceutical analytical development.
Experience with analytical method development, validation, and troubleshooting.
Familiarity with USP, PQRI, and applicable E&L regulatory guidance.
Ability to review complex technical data, mentor scientists, and support client-facing projects.

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.