Senior 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

There’s a reason St. Jude Children’s Research Hospital is consistently ranked on Glassdoor’s “Best Places to Work” list. Actually, there are more than 5,500 reasons. At our world-class pediatric research hospital, every one of our 5,500 professionals shares our commitment to making a difference in the lives of the children we serve. There’s a unique bond when you are part of a team that will stop at nothing to advance the treatments and cures of pediatric catastrophic diseases. The result is a collaborative, positive environment where all employees, regardless of their role, receive the resources, support, and encouragement to advance and grow their careers.

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.

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.

Compensation

A reasonable estimate of the current salary range is $65,520 - $114,400 per year for the role of Senior Manufacturing Specialist.

Equal Opportunity Employer

St. Jude is an Equal Opportunity Employer