GMP, Associate Scientist/Eng-1 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

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Work Arrangement: On-Site

Requisition Number: 274275

Regular or Temporary: Regular

Location: Durham, NC, US, 27710

Date: Aug 27, 2026

GMP ASSOCIATE SCIENTIST/ENGINEER I

GMP Analytics - Duke Human Vaccine Institute

Be You.

Position Overview:

The Associate Scientist I will support the development, qualification and execution of analytical methods to enable optimization of processes, formulations and characterization of vaccine products. This incumbent in this position will be involved in pharmaceutical and analytical development for GMP production of vaccine products and therapeutics.

Minimum Requirements:

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

Preferred Qualifications:

N/A

Be Bold.

Position Description:

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.

Choose Duke.

Join our award-winning team and be part of an inclusive culture that values excellence, innovation, and discovery. Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines. Beyond the engaging work, you'll also benefit from Duke's competitive benefits package, including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.

Job Code: 00003009 GMP, ASSOC SCIENTIST/ENG-1, ANALYTICS

Job Level: 89

Anticipated Pay Range:

Duke University provides an annual base salary range for this position as USD $48,137.00 to USD $86,631.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

Equal Opportunity Employer:

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas - an exchange that is best when the rich diversity of ourperspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions:

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: [e-mail]; phone: [phone]).

Nearest Major Market: Durham

Nearest Secondary Market: Raleigh

Read more about Duke's commitment to affirmative action and nondiscrimination at hr.duke.edu/eeo.