Senior GMP Biologics Manufacturing Specialist

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

Job summary

St. Jude Children’s GMP seeks a Manufacturing Specialist or Senior Manufacturing Specialist to support manufacturing activities in the GMP facility at St. Jude Children’s Research Hospital.

The role involves independent execution of production processes, regulatory compliance, and collaboration across teams to improve SOPs and processes. Minimum 4+ years in production/quality, Bachelor’s in chemistry/biology+; Master’s preferred; experience with cGMP, audits, and quality systems is desirable.

Qualifications

• Bachelor's degree in chemistry, biology or related field required.
• Master's degree preferred.
• 4+ years of experience in production/quality in an industrial setting required.
• Experience with quality/manufacturing regulations (cGMP, cGTP, FACT) preferred.
• Experience with electronic systems used in Quality Management Systems preferred.
• Experience with computerized databases preferred.

Responsibilities

• Independently execute production processes and monitor compliance with FDA/FACT/USDA.
• Collaborate across teams to revise SOPs and process flows for production and quality.
• Monitor production to ensure cGMP compliance by reviewing batch records and logs.
• Lead audits and investigations of deviations; implement corrective actions.
• Monitor and document compliance with quality and regulatory requirements.
• Recommend continuous improvements to production and quality systems.
• Train and supervise others on quality/production regulations and SOPs.

Skills

Quality systems

Regulatory compliance

cGMP knowledge

Auditing

Documentation

Education

Bachelor's degree in chemistry, biology or related field

Master's degree preferred

Tools

QMS software

Databases

Job description

St. Jude Children’s GMP seeks a Manufacturing Specialist or Senior Manufacturing Specialist to support manufacturing activities in the GMP facility at St. Jude Children’s Research Hospital.

The role involves independent execution of production processes, regulatory compliance, and collaboration across teams to improve SOPs and processes. Minimum 4+ years in production/quality, Bachelor’s in chemistry/biology+; Master’s preferred; experience with cGMP, audits, and quality systems is desirable.