Manufacturing Specialist / Senior Manufacturing Specialist- GMP

St. Jude’s Children’s GMP is seeking a dedicated, reliable individual for the role of a Manufacturing Specialist or Senior Manufacturing Specialist to help with manufacturing activities in the GMP facility at St. Jude Children’s Research Hospital. Children’s GMP supports clinical trials on campus at St. Jude through the manufacture of biological drug products – these include viral vectors, monoclonal antibodies, and cellular therapy products.

The  Manufacturing Specialist independently works on the manufacturing of biological products and live viral vaccines for human clinical trials at St. Jude Children’s Research Hospital. Also, collaborates with the team to support continuous improvement and trains and guides the work of others in manufacturing.

Job Responsibilities:

• Independently execute quality/production processes with guidance, to monitor and ensure compliance with all applicable regulatory requirements (e.g., FDA, FACT, USDA).

• Collaborate across teams to support revision/continuous improvement of SOPs and/or process flows related to production/quality/TPQ/HAL.

• Monitor production to ensure cGMP compliance by checking batch records for accuracy and equipment logs for completeness; address critical deviations.

• Lead internal/external audits, investigation of deviations, and identification/implementation of corrective actions.

• Monitor and document compliance with quality and regulatory requirements.

• Guide/make recommendations for continuous improvement of production/quality/ compliance systems using documentation such as release specifications, variances, environmental monitoring reports, and internal audits.

• Regularly train and oversee the work of others in quality/production regulations, systems, and SOPs.

Senior Manufacturing Specialist Requirements

Minimum Education 

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

• Master's degree preferred.

Minimum Experience:

• 4+ years experience in production/quality in industry setting required.

• Working with quality/production systems/processes and their maintenance/implementation, as applicable to own area (e.g. cell processing, cell culture, vector production) preferred.

• Experience working with quality/manufacturing regulations and guidelines (e.g., cGMP, cGTP, FACT) preferred.

• Experience working with electronic systems commonly used in Quality Management Systems, preferred as applicable.

• Experience working with computerized databases preferred as applicable.

• Proven performance in earlier role/ comparable role.

Manufacturing Specialist Requirements

Minimum Education 

• Bachelor's degree in chemistry, biology or related field required.

• Master's degree preferred.

Minimum Experience:

• Minimum Requirement: 2+ years of quality/production experience in industry setting required.

• Experience working with quality/production systems/processes and their maintenance/implementation, as applicable to own area (e.g., cell processing, cell culture, vector production) preferred.

• Some prior experience working with quality/manufacturing regulations and guidelines (e.g., cGMP, cGTP, FACT) preferred.

• Familiarity with electronic systems commonly used in Quality Management Systems, preferred as applicable.

• Experience working with computerized databases preferred.

Compensation

Explore our exceptional benefits!

No Search Firms

St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.