Senior GMP Manufacturing Specialist - Biologics & Trials

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 perform manufacturing activities in the GMP facility.

You will support clinical trials with production of viral vectors, mAbs, and cellular therapy products, and lead continuous improvement efforts while guiding others in quality and regulatory processes. The role requires a Bachelor's in chemistry, biology, or related field (Master's preferred) and 4+ years of production/quality

Qualifications

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

Responsibilities

• Independently execute quality/production processes with guidance to monitor and ensure regulatory compliance.
• Collaborate across teams to support revision/continuous improvement of SOPs and process flows.
• Monitor production to ensure cGMP compliance; address deviations and maintain logs.
• Lead audits, investigations of deviations, and implement corrective actions.
• Train and oversee others in quality/production regulations and SOPs.

Skills

Quality systems

cGMP

Cell processing

Regulatory compliance

Education

Bachelor's degree in chemistry, biology or a related field

Master's degree

Tools

Electronic QA systems

Document control

Job description

St. Jude Children's Research Hospital is seeking a Manufacturing Specialist or Senior Manufacturing Specialist to perform manufacturing activities in the GMP facility.

You will support clinical trials with production of viral vectors, mAbs, and cellular therapy products, and lead continuous improvement efforts while guiding others in quality and regulatory processes. The role requires a Bachelor's in chemistry, biology, or related field (Master's preferred) and 4+ years of production/quality