GMP Lab Operations Director — Compliance & Results

ClinLab Solutions Group; San Antonio (TX); On-site; USD 180,000 - 260,000; Full time

Job summary

ClinLab Solutions Group in Texas seeks a Director to oversee a GMP service laboratory, ensuring on-time, validated, audit-ready results. The role blends microfluidics and human cell culture with quality and regulatory discipline for biopharma clients.

You will lead audits, manage the LIMS and data workflow, mentor scientists, and collaborate with Business Development on studies and budgets, while maintaining a compliant, high-performance lab culture.

Qualifications

• PhD in bioengineering, biomedical engineering, cell biology, immunology, or a related field.
• 8+ years post-PhD experience, or 12+ years with a Master’s degree.
• 4+ years managing scientists.
• Hands-on work in microfluidics or organ-on-chip systems with human primary cells.
• Leadership in a GMP laboratory, including hosting audits or inspections.
• Assay qualification and validation, including written plans and reports you authored.
• Implementing or administering a LIMS or ELN and managing regulated data.
• Contributing to regulatory filings (IND, BLA, or equivalent), such as CMC or nonclinical sections.

Responsibilities

• Own GMP compliance for the laboratory and maintain the quality system to support audits/inspections.
• Lead end-to-end lab service delivery from receipt to results release within turnaround times.
• Serve as the senior technical contact for clients and coordinate study kickoffs and result presentations.
• Write and approve validation master plans and regulatory-ready study reports and data packages.
• Oversee LIMS configuration, validation, and data management under 21 CFR Part 11 controls.
• Own assay qualification and validation for all lab readouts and related documentation.
• Support regulatory filings with technical sections and liaise with FDA during discussions.
• Forecast and schedule organ-on-chip devices, instruments, and staff; protect client IP.
• Train and develop the scientific team, set goals, and foster a compliant, high-performing culture.
• Partner with Business Development on SOWs, quality agreements, study design, and lab budgeting.

Skills

GMP expertise

LIMS management

Regulatory compliance

Team leadership

Client management

Education

PhD in bioengineering or related field

Tools

LIMS/ELN systems

Job description

ClinLab Solutions Group in Texas seeks a Director to oversee a GMP service laboratory, ensuring on-time, validated, audit-ready results. The role blends microfluidics and human cell culture with quality and regulatory discipline for biopharma clients.

You will lead audits, manage the LIMS and data workflow, mentor scientists, and collaborate with Business Development on studies and budgets, while maintaining a compliant, high-performance lab culture.