GMP Analytical Scientist I – Vaccine Development

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

Benefits offered by this job

Health insurance

Paid time off

Retirement plan

Tuition assistance

Job summary

Duke University invites applications for the GMP Associate Scientist/Engineer I within the GMP Analytics – Duke Human Vaccine Institute. The role supports development, qualification, and execution of analytical methods for GMP production of vaccine products and therapeutics.

The successful candidate will typically hold a bachelor’s degree in a science, engineering, or related field and contribute to analytical development, method qualification, formulation development, and regulatory-compliant

Qualifications

• Generally requires a bachelor's degree in a science, engineering, or related field.

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.
• Complete GMP testing in line with ICH and regulatory guidance.
• Formulation development Develop formulations to stabilize vaccine products.
• Employ analytical characterization tools to inform product formulation design
• Lead formulation & filling of vaccine products including, tech transfer and production under GMP conditions.
• Execute and document development and GMP activities in compliance with regulatory requirements.
• Collaborate closely with other development teams to provide support for development activities and will work diligently with other development functions to understand how the production process changes impact product quality.
• Compile data and perform analysis and interpretation and draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making; summarize data, present results and propose next steps to advance development.
• Write and reviews development reports; writes protocols for tech transfer and SOPs for GMP production, and presents data to project teams and larger settings.

Education

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

Job description

Duke University invites applications for the GMP Associate Scientist/Engineer I within the GMP Analytics – Duke Human Vaccine Institute. The role supports development, qualification, and execution of analytical methods for GMP production of vaccine products and therapeutics.

The successful candidate will typically hold a bachelor’s degree in a science, engineering, or related field and contribute to analytical development, method qualification, formulation development, and regulatory-compliant