Senior Manufacturing Specialist

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

60d•$65,520 - $114,400•Onsite

About The Position

St. Jude Children’s Research Hospital is seeking a dedicated and reliable individual for the role of a Manufacturing Specialist or Senior Manufacturing Specialist to assist with manufacturing activities in the GMP facility. The Children’s GMP department supports clinical trials by manufacturing biological drug products, including viral vectors, monoclonal antibodies, and cellular therapy products. The Manufacturing Specialist will independently work on the manufacturing of biological products and live viral vaccines for human clinical trials, while also collaborating with the team to support continuous improvement and train/guide the work of others in manufacturing.

Requirements

Bachelor's degree in chemistry, biology or a related field required.
4+ years experience in production/quality in industry setting required.
Proven performance in earlier role/ comparable role.

Nice To Haves

Master's degree preferred.
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.

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.