Cell Therapy cGMP Production Specialist

Houstonmethodistcareers; Houston (TX); On-site; USD 95,000 - 120,000; Full time

Job summary

Houston Methodist Research Institute is seeking a cGMP Specialist I for Clinical Cell Therapy. You will support manufacturing of cell-based therapies and nucleic acid therapies under cGMP/cGTP, ensuring sterility, traceability and regulatory compliance across units.

You will participate in audits, mentor staff, and contribute to continuous improvement while upholding SOPs and quality standards within a fast-paced, life-saving program.

Qualifications

• Bachelor’s degree or higher; Master’s preferred in a relevant field.
• Three years of biotech/pharmaceutical cGMP manufacturing experience.

Responsibilities

• Collaborates with cross functional teams including research, process development, quality assurance and quality control.

Skills

Sterile gowning

Cleanroom behavior

Aseptic technique

cGMP & data integrity

Regulatory knowledge (FDA/GLP)

Software proficiency (MS Office)

Mentoring & coaching

Regulatory audits & inspections

Education

Bachelor’s degree

Master’s degree preferred

Job description

Houston Methodist Research Institute is seeking a cGMP Specialist I for Clinical Cell Therapy. You will support manufacturing of cell-based therapies and nucleic acid therapies under cGMP/cGTP, ensuring sterility, traceability and regulatory compliance across units.

You will participate in audits, mentor staff, and contribute to continuous improvement while upholding SOPs and quality standards within a fast-paced, life-saving program.