Share this Job

 
Duke University and Duke University Health System require all students, faculty and staff to receive the COVID-19 and influenza vaccines.  After you have officially accepted a position at Duke, you may request a religious or medical accommodation.

Associate Scientist II, GMP Analytical Team

Work Arrangement: 
Requisition Number:  168139
Regular or Temporary:  Regular
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER
Date:  Sep 22, 2022

This Position is Fully Grant Funded

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

Associate Scientist II, GMP Analytical Team

Duke Human Vaccine Institute (DHVI)

 

Role Description:

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.

 

 

Responsibilities:

  • 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.

 

 

Preferred Qualifications:

 

  • 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.

 

Minimum Qualifications

 

 

Education

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

 

Duke 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 essentialjob 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.

 


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh