Senior Manufacturing Specialist

St. Jude Children's Research Hospital; Lauderdale Courts (TN); On-site; USD 66,000 - 114,000; Full time

Job summary

St. Jude Children's Research Hospital is seeking a Manufacturing Specialist or Senior Manufacturing Specialist to support GMP manufacturing of biological products for clinical trials at the St.

Jude GMP facility. The role requires a Bachelor's in chemistry or biology with 4+ years in production/quality; a Master's is preferred, and familiarity with cGMP, cGTP, FACT; ability to collaborate across teams and lead audits is essential.

Qualifications

• Bachelor's degree in chemistry, biology or a related field required.
• Master's degree preferred.
• 4+ years of experience in production/quality in an industrial setting.
• Experience with cGMP, cGTP, FACT and related regulations preferred.
• Experience with electronic quality management systems or databases preferred.

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.

Skills

Quality systems experience

cGMP knowledge

Education

Bachelor's degree in chemistry/biology

Master's degree preferred

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 as applicable.
• Proven performance in earlier role/ comparable role.

Compensation

In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $65,520 - $114,400 per year for the role of Senior Manufacturing Specialist.

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St. Jude is an Equal Opportunity Employer