Research and Development
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Job: GMP Associate Scientist II - Analytics (100997), Duke Human Vaccine Institute, Durham, NC
GMP Associate Scientist II - Analytics (100997)
Durham, NC 27710 United States
Research and Development
The GMP Analytical Team at DHVI is seeking a colleague who will work on the development, qualification/validation and execution of analytical and biophysical assays to support the characterization of novel protein and RNA vaccine products. She/he will provide comprehensive analytical support from the early clone selection stage to the final purification stage of the product. The assays will be suitable for the characterization of quality attributes during downstream process development and for release and stability testing. The successful candidate will have expertise in a broad range of analytical and biophysical techniques, e.g., advance liquid chromatography methods, ligand binding and cell-based assays. The ability to execute and document analytical methods in a regulatory compliant manner is essential.
• Participate in the development and execution of robust and reliable analytical assays for the characterization of vaccine quality attributes using a range of potential analytical platforms.
• Support optimization of methods during process development by providing key analytical information regarding the quality of the potential vaccine product.
• Perform data analysis and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making.
• Assist in the development of new methodologies in analytical/biophysical and antigenicity testing of vaccine products.
• Operate in a GMP regulated environment, follow departmental SOPs and Regulatory guidelines.
Required Qualifications at this Level
• Education/Training: Bachelor's degree in a science, engineering, or related field. An advanced degree (Master's, PhD) is preferred.
• Experience: 4 years relevant experience in the biopharmaceutical industry or equivalent
• BS/MS with 4+ years of relevant industry experience with a focus on analytical assay development.
• Knowledge and hands-on experience developing analytical assays utilizing various platforms (experience in advanced liquid chromatography and ligand binding assays is expected; experience in DSC, DLS and cell-based assays is a plus).
• Demonstrated ability in troubleshooting complex analytical problems.
• Proven ability to generate high quality data and documentation within challenging time lines.
• Excellent oral and written communication skills, attention to detail and collaboration skills
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North Carolina Biotechnology Center