Senior Manufacturing Specialist

St. Jude Children's Research Hospital • Memphis, TN

71d • $65,520 - $114,400 • Onsite

About The Position

St. Jude Children’s Research Hospital is seeking a Senior Manufacturing Specialist to support manufacturing activities in its GMP facility. Children’s GMP supports St. Jude clinical trials by manufacturing biological drug products, including viral vectors, monoclonal antibodies, and cellular therapy products. The role independently carries out manufacturing of biological products and live viral vaccines for human clinical trials, collaborates with the team on continuous improvement, and trains and guides the work of others.

Requirements

• Bachelor’s degree in chemistry, biology, or a related field.
• At least 4 years of experience in production or quality in an industry setting.
• Proven performance in an earlier or comparable role.

Nice To Haves

• Master’s degree.
• Experience with quality and production systems or processes and their maintenance or implementation, as applicable to the area, such as cell processing, cell culture, or vector production.
• Experience with quality and manufacturing regulations and guidelines, such as cGMP, cGTP, or FACT.
• Experience with electronic systems commonly used in Quality Management Systems, as applicable.
• Experience with computerized databases, as applicable.

Responsibilities

• Independently execute quality and production processes, with guidance, to monitor and ensure compliance with applicable regulatory requirements, including FDA, FACT, and USDA requirements.
• Collaborate across teams to revise and continuously improve SOPs and process flows related to production, quality, TPQ, and HAL.
• Monitor production for cGMP compliance by checking batch records for accuracy and equipment logs for completeness, and address critical deviations.
• Lead internal and external audits, investigate deviations, and identify and implement corrective actions.
• Monitor and document compliance with quality and regulatory requirements.
• Recommend and guide continuous improvement of production, quality, and compliance systems using documentation such as release specifications, variances, environmental monitoring reports, and internal audits.
• Train and oversee others in quality and production regulations, systems, and SOPs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior