Senior Manufacturing Specialist
St. Jude Children's Research Hospital
Summary
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.
Job description
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.
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.
Requirements
- 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
- Working with quality/production systems/processes and their maintenance/implementation 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
- Experience working with computerized databases preferred
- Proven performance in earlier role/comparable role
Benefits
- Benefits available
Company overview
St. Jude Children's Research Hospital is a world-renowned pediatric research and treatment institution headquartered in Memphis, Tennessee, dedicated to advancing cures for childhood cancer and other catastrophic diseases. Founded in 1962 by entertainer Danny Thomas, it stands as the first and only National Cancer Institute-designated Comprehensive Cancer Center devoted exclusively to children. The hospital operates on a unique funding model where families never receive bills for treatment, travel, housing, or food, with costs exceeding $2 billion annually primarily supported by donations through its fundraising organization ALSAC. St. Jude treats approximately 8,600 patients each year from all 50 states and around the world, with a focus on acute lymphoblastic leukemia, brain tumors, sickle cell disease, and infectious diseases. The institution employs over 7,000 staff members and maintains eight affiliate clinics across the United States. Through its St. Jude Global initiative, the hospital shares research and treatment protocols internationally, partnering with more than 350 institutions in over 90 countries. St. Jude has been instrumental in increasing childhood cancer survival rates from 20% in 1962 to over 80% today, while maintaining a robust research program that includes gene therapy, bone marrow transplantation, and precision medicine approaches.