GMP, SCIENTIST I, ANALYTICS
GMP, SCIENTIST I, ANALYTICS
Duke Human Vaccine Institute - Admin
GMP SCIENTIST I - ANALYTICS
The GMP Scientist - Analytics will work on the development, qualification/validation and execution of analytical and biophysical assays to support the characterization of vaccine products. The position will provide comprehensive analytical support from the early clone selection stage to the final purification stage of the product and ensure the assays will be suitable for the characterization of quality attributes during downstream process development and for release and stability testing.
- Responsible for the development of robust and reliable analytical assays for the characterization of vaccine quality attributes using a range of potential analytical platforms.
- Work closely with the down-stream processing team and 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.
- BS/MS with 6+ 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).
- Expertise in a broad range of analytical and biophysical techniques, e.g., UPLC, capillary electrophoresis, ligand binding and cell-based assays.
- 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.
- Ability to execute and document analytical methods in a regulatory compliant manner.
3011 GMP, SCIENTIST/ENG-1, ANALYTICS
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, gender, gender expression, genderidentity, 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 robustexchange of ideas—an exchange that is best when the rich diversity ofour perspectives, backgrounds, and experiences flourishes. To achievethis exchange, it is essential that all members of the community feelsecure and welcome, that the contributions of all individuals arerespected, and that all voices are heard. All members of our communityhave a responsibility to uphold these values.
Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Bachelor's degree in a science, engineering, or related field. Anadvanced degree (Master's, PhD) is preferred.
6 years relevant experience in the biopharmaceutical industry orequivalent.
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.