GMP Lab Operations Lead - Data-Driven & Safety Focus

Jobtailor; Lebanon (KY); On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor in the United States is seeking a Laboratory Operations Manager to lead day-to-day operations of analytical laboratories supporting process development, characterization, technology transfer, GMP testing, and manufacturing support.

You will ensure lab readiness for new programs and equipment, develop capacity forecasts, drive digital workflows, uphold safety and quality systems, and collaborate across Analytical, Process Development, Manufacturing and Quality groups to enable scalable

Qualifications

• Bachelor's degree in chemistry, biology, or related scientific field.
• Minimum 5+ years in regulated pharmaceutical/chemical/biotech or process development labs.
• Experience managing laboratory operations in a regulated environment.
• Authorized to work in the United States on a full-time basis.
• No visa sponsorship provided.
• Knowledge of analytical instrumentation (HPLC, UPLC, GC, LC-MS, dissolution, spectroscopy, particle characterization, microbiological testing).
• Experience with equipment qualification, validation and lifecycle management.
• Familiarity with LIMS, Empower, ELN, Kneat, CMMS and lab digital systems.
• Strong understanding of regulatory requirements, data integrity, and quality systems.
• Proven ability to lead cross-functional teams and influence outcomes.
• Ability to work on-site 8-hour days, five days per week.
• Flexibility to support shutdowns and weekend activities.
• 0–10% travel required.

Responsibilities

• Lead day-to-day operations of analytical labs for process development and GMP testing.
• Ensure laboratory readiness for new programs, equipment installations, method transfers, and expansions.
• Develop laboratory resource plans, schedules, and capacity forecasts.
• Serve as the primary escalation point for laboratory operational issues.
• Foster a strong safety culture and ensure HSE and quality compliance.
• Maintain inspection readiness and support regulatory inspections and audits.
• Apply 5S and ALCOA principles to maintain an organized, compliant lab environment.
• Oversee equipment lifecycle management including procurement, installation, qualification, calibration, maintenance, relocation, and retirement.
• Partner with Engineering and Laboratory Equipment Support Group to ensure equipment reliability and availability.
• Manage laboratory asset inventories, consumables, reagents, standards, and critical materials.
• Monitor equipment utilization and performance metrics and develop improvement plans.
• Lead laboratory productivity, automation, digitalization, and operational excellence initiatives.
• Drive implementation of digital workflows.
• Use data-driven metrics to identify performance gaps and improvement opportunities.
• Promote collaboration across analytical, process development, manufacturing, and quality organizations.
• Support strategic laboratory expansion and organizational scaling plans.

Skills

Laboratory Operations Management

Analytical Instrumentation Expertise

Regulatory Compliance Knowledge

Cross-Functional Team Leadership

Equipment Lifecycle Management

Education

Bachelor's degree in chemistry or biology or related scientific discipline

Tools

LIMS

Empower

ELN

Kneat

CMMS

Job description

Jobtailor in the United States is seeking a Laboratory Operations Manager to lead day-to-day operations of analytical laboratories supporting process development, characterization, technology transfer, GMP testing, and manufacturing support.

You will ensure lab readiness for new programs and equipment, develop capacity forecasts, drive digital workflows, uphold safety and quality systems, and collaborate across Analytical, Process Development, Manufacturing and Quality groups to enable scalable