GMP Analytical Scientist II (RNA)
GMP Analytical Scientist II (RNA)
Duke Human Vaccine Institute - Admin
Associate Scientist II - RNA
The Associate Scientist II will support the development, qualification and execution of analytical methods to enable optimization of processes, formulations and characterization of vaccine products. This position will be involved in pharmaceutical and analytical development for GMP production of vaccine products and therapeutics.
- Develop, optimize and troubleshoot analytical assays for RNA characterization studies and quality control activities
- Develop robust cell based assays (ELISA, FACS, potency) to support product development
- Perform analytical assays using a broad range of techniques including multiple advanced chromatography and ligand binding methods
- Compose and execute standard test methods, assay qualification protocols and reports
- Work closely with the Analytical and Formulation teams to develop product specifications for release testing
- Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making
Education and Experience:
- BS/MS in Cell Biology, Biochemistry or related field with 4+ years of industry experience in oligonucleotide, biologics, and/or biotech drug development
- Experience with RNA-related analytics (e.g. RiboGreen assays, gel electrophoresis, qPCR) and other molecular biology techniques
- Experience in nucleic acid production and characterization assays.
- Experience mammalian cell culture, cell based assays, RNA production and purification preferred
- Experience with biochemical/biophysical methods, e.g., SPR, ELISA, DLS and UPLC, is a plus.
- Experience with analytical characterization techniques including light scattering, UPLC methods, capillary electrophoresis, enzymology
- Knowledge of nucleic acid chemistry and biology
- Knowledge of GMP and GLP compliance
- Experience in analytical method validation to support GMP quality control laboratory operations preferred
3010 GMP, ASSOC SCIENTIST/ENG-2, ANALYTICS
Job Family Level
Full Time / Part Time
Regular / Temporary
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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.
Bachelor's degree in a science, engineering, or related field. An advanced degree (Master's, PhD) is preferred.
4 years relevant experience in the biopharmaceutical industry or equivalent
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
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.