Senior Manufacturing Specialist (Biologics)

Location: Memphis, Tennessee, United States

Salary: $65,520–$114,400 per year

Company

hirify.global operates a pediatric research hospital and a Children's GMP facility supporting clinical trials through the manufacture of biological drug products.

What you will do

• Independently execute quality and production processes for biological products and live viral vaccines.
• Monitor batch records, equipment logs, production activities, and compliance with applicable FDA, FACT, USDA, and GMP requirements.
• Collaborate across teams to revise and continuously improve SOPs, process flows, and production and quality systems.
• Lead internal and external audits, investigate deviations, and implement corrective actions.
• Train and guide employees on quality and production regulations, systems, and SOPs.

Requirements

• Bachelor's degree in chemistry, biology, or a related field.
• At least 4 years of production or quality experience in an industry setting.
• Proven performance in an earlier or comparable role.
• Experience with production and quality systems, computerized databases, and electronic quality management systems is preferred.
• Experience with cGMP, cGTP, FACT, cell processing, cell culture, or vector production is preferred.

Nice to have

• Master's degree in chemistry, biology, or a related field.
• Experience maintaining or implementing quality and production processes.

Culture & Benefits

• Collaborative, positive work environment in a pediatric research hospital.
• Resources, support, and encouragement for professional growth.
• Benefits are available through hirify.global.
• Human-centered hiring process with human review and engagement.

Hiring process

• Recruiting decisions include human review and engagement; technology may support parts of the process.