GMP Associate Scientist/Engineer I - Vaccine Analytics

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

Job summary

Duke University in Durham, NC is seeking an Associate Scientist I to support analytical development, qualification and GMP release of vaccine products within the GMP Analytics team of the Duke Human Vaccine Institute.

The role covers analytical development, method qualification for product release, GMP testing per ICH guidelines, and collaboration across development teams to ensure product quality and successful tech transfer under GMP conditions.

Qualifications

• Bachelor's degree in a science, engineering, or related field is generally required.

Responsibilities

• Analytical development and GMP release activities for vaccine products.
• Qualify methods for product release and characterize clinical lots.
• Perform GMP testing in line with ICH/regulatory guidance.
• Develop formulations to stabilize vaccine products.
• Lead formulation and filling under GMP conditions and support tech transfer.
• Document development activities and summarize results for decision making.
• Write protocols for tech transfer and SOPs for GMP production.

Education

Bachelor's degree in a science, engineering, or related field

Job description

Duke University in Durham, NC is seeking an Associate Scientist I to support analytical development, qualification and GMP release of vaccine products within the GMP Analytics team of the Duke Human Vaccine Institute.

The role covers analytical development, method qualification for product release, GMP testing per ICH guidelines, and collaboration across development teams to ensure product quality and successful tech transfer under GMP conditions.