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Job Code: 3003
Job Level: 68
Revised Date: 04/07/2018
Job Family: JF 05

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Occupational Summary

The Associate Scientist I will support the development, tech transfer, and GMP execution of production processes for innovative vaccine products. This position will be involved in bioprocess development and GMP production, including lab scale process development; scale up and tech transfer of the process into the GMP suite, and execution of the process under GMP compliant conditions.

Work Performed

Perform Upstream and/or Downstream aspects of lab scale process development and GMP production including:

Upstream techniques Cell culture development (ex. CHO, 293, insect cell)

Growth media selection and optimization

Derivation and characterization of stable cell lines

Downstream techniques Chromatography development: Resin screening (IEX, HIC, Mix-Mode, Affinity, SEC), optimization, and robustness testing.

Filtration Development: Development of various filtration techniques including ultrafiltration/diafiltration, depth filtration, viral filtration, sterile filtration.

GMP Production: Process scale up, tech transfer, and execution of the process under GMP conditions.

Execute and document development and GMP activities in compliance with regulatory requirements.

Support CGMP production, including equipment and material management, to ensure facilities and materials meet DHVI needs, perform investigations.

Provide support for cGMP campaigns, including documentation, deviation and root cause analysis.

Collaborate closely with other development teams to provide support for development activities and will work diligently with cell line development and analytical development functions to understand how the production process is impacts 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 and present results.

Write and reviews technical development reports; assist with writing protocols for tech transfer and SOPs for GMP production, and present 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 cell culture or protein purification techniques and basic analytical techniques; hands on implementation of bioprocess unit operations (bioreactor control and operation, Chromatography, TFF filtration, GE Unicorn software) and/or direct GMP experience is preferred

Experience in either upstream (cell culture, bioreactor operation including scale up) or downstream purification (chromatography, tangential flow filtration, normal flow filtration) and basic analytical techniques to support upstream or downstream activities (cell and metabolite analyses, SDS-PAGE, western blot, UV-Vis, colorimetric methods).

Must have the ability to works independently to develop specific processes or methods 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.