GMP Analytics Scientist I - Vaccine Development

Duke Clinical Research Institute; Durham (NC); On-site; USD 48,000 - 87,000; Full time

Job summary

Duke University is seeking an Associate Scientist I for GMP analytics within the Duke Human Vaccine Institute to support analytical method development, qualification, and GMP production of vaccine products. The role involves collaborative pharmaceutical development, technology transfer, and regulatory-compliant documentation.

The incumbent will perform analytical development, release testing, formulation development, and data interpretation to inform product design and quality.

Qualifications

• Bachelor's degree in a science, engineering, or related field is generally required.
• Analytical development and GMP release experience are expected.
• Formulation development to stabilize vaccine products is described.
• Lead formulation and filling of vaccine products including tech transfer under GMP.

Responsibilities

• Perform pharmaceutical development and successful GMP release including analytical development.
• Develop product-specific release and characterization methods.
• Qualify methods for product release and complete comprehensive characterization of clinical lots.
• Formulation development to stabilize vaccine products; employ analytical tools to inform formulation design.
• Lead formulation and filling of vaccine products including tech transfer under GMP.
• Execute and document development and GMP activities in compliance with regulatory requirements.
• Collaborate with other development teams to support activities and understand production impact on quality.
• Compile data, analyze results, and present conclusions to advance development.

Skills

Analytical development

GMP release

Tech transfer

Vaccine analytics

Education

Bachelor's degree in a science/engineering

Job description

Duke University is seeking an Associate Scientist I for GMP analytics within the Duke Human Vaccine Institute to support analytical method development, qualification, and GMP production of vaccine products. The role involves collaborative pharmaceutical development, technology transfer, and regulatory-compliant documentation.

The incumbent will perform analytical development, release testing, formulation development, and data interpretation to inform product design and quality.