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Job Code: 3009
Job Level: 89
Revised Date: 04/07/2018
Job Family: JF 05

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Occupational Summary

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.

Work Performed

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.

Required Qualifications at this Level


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




Knowledge and hands on classwork with analytical methods and/or product formulation.

Hands on experience with specific analytical methods (HPLC, immunoassays, biochemical methods), molecular or pharmaceutical product formulation (buffer & excipient screening, thermal stability evaluation, biophysical methods) is preferred. GMP experience is a plus

Must have the ability to work independently with guidance from senior scientists/managers.

Demonstrated ability in solving moderately complex analytical problems with guidance from senior development scientists.

Strong oral and written communication skills

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Duke University is an Affirmative Action/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, sexual orientation, or veteran 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 our perspectives, 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 provision for requests for reasonable accommodation will be provided by each hiring department.