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

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

Shift

M-F 8:00am-4:30pm

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

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

Analytical Development | GMP CRO Environment

Location:

On-site

Schedule:

Full-Time M- F Dayshift

Position Summary

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.

Key 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.

Qualifications

• 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.

Preferred Technical Skills

• 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.

What Success Looks Like

The successful candidate will build a high-performing team that consistently delivers quality results, meets client expectations, maintains regulatory compliance, and supports the continued growth of the E&L business within a dynamic analytical development environment.

Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.

Benefits

When you join Pace®, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

Equal Opportunity Employer

Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.