Senior Biotech GMP Manufacturing Specialist

St. Jude Children's Research Hospital; Memphis (TN); On-site; USD 66,000 - 114,000; Full time

Job summary

St. Jude Children’s Research Hospital is seeking a Manufacturing Specialist or Senior Manufacturing Specialist to support GMP manufacturing of biological products for clinical trials.

The role requires leading quality/production processes, ensuring regulatory compliance, and collaborating to improve SOPs and processes. You will monitor batch records, assist audits, and train team members while contributing to ongoing improvements in manufacturing quality systems within a world‑class pediatric

Qualifications

• Bachelor's degree in chemistry or biology or a related field is required.
• Master's degree is preferred.
• 4+ years of experience in production/quality in industry setting is required.
• Experience with quality/manufacturing regulations (cGMP, cGTP, FACT) preferred.

Responsibilities

• Independently execute quality/production processes with guidance to monitor regulatory compliance (FDA/FACT/USDA).
• Collaborate across teams to improve SOPs and process flows for production/quality/TPQ/HAL.
• Monitor production to ensure cGMP compliance and accurate batch records and equipment logs.
• Lead internal and external audits, investigate deviations, and implement corrective actions.
• Monitor and document compliance with quality and regulatory requirements.
• Train and oversee others in quality/production regulations, systems, and SOPs.

Skills

Quality systems

cGMP compliance

Auditing

Training & mentorship

Education

Bachelor's degree in chemistry/biology or related field

Master's degree preferred

Tools

QMS software

Electronic databases

Job description

St. Jude Children’s Research Hospital is seeking a Manufacturing Specialist or Senior Manufacturing Specialist to support GMP manufacturing of biological products for clinical trials.

The role requires leading quality/production processes, ensuring regulatory compliance, and collaborating to improve SOPs and processes. You will monitor batch records, assist audits, and train team members while contributing to ongoing improvements in manufacturing quality systems within a world‑class pediatric