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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:  177108
Regular or Temporary:  Regular
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER
Date:  Aug 8, 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

 

Role Description:

The GMP Analytical Team at DHVI is seeking a colleague who will work on the oversight, development and execution of activities to support environmental monitoring of the cGMP facility to ensure compliance with regulatory expectations as well as microbiological testing, e.g., bioburden, for protein and RNA vaccine products.  Additionally, the candidate will ensure the smooth running of the analytical laboratory and manage procurement, equipment maintenance and shipping activities. The successful candidate should have knowledge and hands-on experience with microbiological methods and supervisory experience.  The ability to execute and document analytical methods in a regulatory compliant manner is essential.

 

Responsibilities:

  • Manage and perform environmental monitoring activities including sampling, testing, species identification, and data review/documentation.  Responsibilities include the supervision of junior staff. 
  • Development, validate and execute microbiological assays for bioburden analysis of protein and RNA vaccine candidates for lot release.
  • Manage the day-to-day operations within the Analytical Laboratory including procurement of supplies and inventory management, scheduling equipment qualification and maintenance activities and coordination of biological shipments. 
  • Perform data analysis and review and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making.
  • 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 environmental monitoring and microbiological methods
  • Knowledge and hands-on experience developing microbiological assays is expected (experience with rapid microbial methods utilizing the Growth Direct® platform and species identification using MALDI-TOF is a plus).
  • Supervisory experience is preferred.
  • 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.

 

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

 

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.

 


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Nearest Secondary Market: Raleigh