GMP Lab Operations Lead - Build Processes & Compliance

Stanley Cowton International; Pennsylvania; On-site; USD 140,000 - 150,000; Full time

Job summary

Stanley Cowton International in Pennsylvania is seeking a hands-on Laboratory Operations Manager to bring structure and pace to a GMP quality laboratory. You will lead a small technical team, own day-to-day lab operations, ensure compliance, and prepare the site for regulatory inspections.

This role focuses on building systems, refining SOPs, managing stability studies, and coordinating with QA, scientific and operations colleagues to deliver reliable results and audit readiness.

Qualifications

• Degree in life sciences or chemistry.
• Extensive GMP pharmaceutical/biotech lab operations experience including people management.
• Hands-on with stability programmes and GMP sample/inventory control.
• Solid knowledge of chromatography systems and lab data software.
• Experience supporting FDA or equivalent regulatory inspections.
• Proven track record of improving lab systems and processes.
• Willingness to work a shift-based schedule as required.

Responsibilities

• Lead and develop a team of laboratory technicians.
• Own lab operations including sample management, inventory, equipment upkeep and housekeeping.
• Manage stability studies in line with GMP and ICH requirements.
• Keep the lab audit-ready and support regulatory inspections.
• Collaborate with QA, scientific and operations teams to ensure readiness.
• Work with vendors to keep instruments running and resolve issues quickly.
• Develop and improve SOPs, training and maintenance programs.

Skills

Team leadership

GMP operations

Stability studies

Lab inventory management

Chromatography systems

Lab data software

Regulatory inspections (FDA)

Education

Life sciences or chemistry degree

Tools

Chromatography hardware

LIMS

Job description

Stanley Cowton International in Pennsylvania is seeking a hands-on Laboratory Operations Manager to bring structure and pace to a GMP quality laboratory. You will lead a small technical team, own day-to-day lab operations, ensure compliance, and prepare the site for regulatory inspections.

This role focuses on building systems, refining SOPs, managing stability studies, and coordinating with QA, scientific and operations colleagues to deliver reliable results and audit readiness.