Clinical Cell Therapy: cGMP Specialist

Houston Methodist; Houston (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

Houston Methodist cGMP Specialist I / Production supports complex manufacturing of cell therapy products and nucleic acid-based therapies under cGMP/cGTP. You will ensure sterility, traceability, and compliance while supporting quality systems and audits.

The role requires a Bachelor’s degree (Master’s preferred) and at least three years in biotech/pharma with cGMP exposure; ability to work in a fast-paced environment and collaborate across teams.

Qualifications

• Bachelor’s degree required; Master’s preferred.
• 3 years of experience in biotechnology or pharmaceutical industry with exposure to cGMP manufacturing operations.
• Experience performing IQ/OQ/PQ, facility commissioning, internal/external audits, batch record review and hosting regulatory inspections preferred.
• Proficiency in spreadsheet, word processing and presentation software.

Responsibilities

• Collaborates with cross functional teams including research, process development, quality assurance and quality control.
• Works with research team members to assist them with transitioning their research processes to compliant cGMP SOPs.
• Participates in multi-functional project teams, as necessary.

Skills

Sterile gowning

Cleanroom behavior

Aseptic technique

cGMP principles

Data integrity

Environmental monitoring

Labeling & traceability

Communication skills

FDA regulatory

Spreadsheet proficiency

Education

Bachelor’s degree

Master’s degree preferred

Job description

Houston Methodist cGMP Specialist I / Production supports complex manufacturing of cell therapy products and nucleic acid-based therapies under cGMP/cGTP. You will ensure sterility, traceability, and compliance while supporting quality systems and audits.

The role requires a Bachelor’s degree (Master’s preferred) and at least three years in biotech/pharma with cGMP exposure; ability to work in a fast-paced environment and collaborate across teams.