Job: GMP Analytical Scientist I - Human Vaccine Institute, Duke Human Vaccine Institute, Durham, NC
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., UPLC, capillary electrophoresis, ligand binding and cell-based assays. The ability to execute and document analytical methods in a regulatory compliant manner is essential.
• Responsible for the development 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.
• Operate in a GMP regulated environment, follow departmental SOPs and Regulatory guidelines.
• Perform data analysis and interpretation 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.
• Act as point of contact to provide analytical support, participate and present in project meetings
You will only be considered for the position after you have applied to requisition 14070 on the DHVI careers page and/or Duke Careers Website.
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.
• BS/MS with 5+ 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 and cell-based assays is a plus).
• Demonstrated ability in solving 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.