cGMP Specialist: Clinical Cell Therapy Production

Houston Methodist; Houston (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Houston Methodist Academic Institute is seeking a cGMP Specialist I to lead complex, time-sensitive processing of cellular therapy products including CAR-T and MSCs under cGMP and cGTP guidelines. You will support manufacturing, documentation, and regulatory compliance within the Office of Translational Production & Quality.

After structured training, you will perform aseptic processing, environmental monitoring, and product tracing while collaborating with research, QA, and manufacturing teams

Qualifications

• Three years of experience in biotechnology or pharmaceutical industry with exposure to cGMP manufacturing operations.
• Experience performing equipment validation (IQ/OQ/PQ), facility commissioning, audits, batch record review, and regulatory inspections preferred.

Responsibilities

• Collaborates with cross functional teams including research, process development, QA and QC.
• Participates in internal audits and external inspections by Regulatory Agencies.
• Maintains accurate documentation and ensures compliance with regulatory standards (FDA, cGMP).
• Supports cleanroom operations and material handling under aseptic conditions.

Skills

Sterile gowning

Cleanroom behavior

Aseptic technique

Data integrity

Education

Bachelor’s degree

Master’s degree preferred

Job description

Houston Methodist Academic Institute is seeking a cGMP Specialist I to lead complex, time-sensitive processing of cellular therapy products including CAR-T and MSCs under cGMP and cGTP guidelines. You will support manufacturing, documentation, and regulatory compliance within the Office of Translational Production & Quality.

After structured training, you will perform aseptic processing, environmental monitoring, and product tracing while collaborating with research, QA, and manufacturing teams