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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.

Senior Bioprocess Engineer

Work Arrangement: 
Requisition Number:  199769
Regular or Temporary:  Regular
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER
Date:  Jan 17, 2023
School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Senior Bioprocess Engineer

Duke Human Vaccine Institute

 

Role Summary

The Senior Bioprocess Engineer will lead the development, tech transfer, and GMP execution of production processes for innovative vaccine products. This position will be involved in bioprocess development and GMP production, including lab scale process development; scale up and tech transfer of the process into the GMP suite, and execution of the process under GMP compliant conditions.

Responsibilities

  • Advise management on strategic direction and focus of technical programs.
  • Demonstrate bioprocess innovation and capabilities to develop suitable bioprocesses.
  • Use experience in leverage risk assessment to foster understanding and comprehensive collaborative decision making.
  • Use knowledge of end to end process for manufacturing, experience working in a CDMO environment, supply chain awareness, technology transfer, authoring draft manufacturing batch records, bill of materials, process flow diagrams, process description documents and collaboration with GMP manufacturing teams.
  • Facilitate team data review and discussion at group meetings and larger team settings.
  • Lead review of technical development reports; write and review protocols for tech transfer and SOPs for GMP production and present data to project teams and larger settings.

 

Education and Experience

Bachelor’s degree in science, engineering, or related field. An advanced degree (Master’s, PhD) is preferred. Plus 13 years relevant experience in the biopharmaceutical industry or equivalent.

Required Skills

  • Expertise in CHO and mammalian cell culture, suspension bioreactor platforms, process scaling up 3-40-200 L, single use technologies including ambr15 and ambr250, media development, cell line development, cell culture harvest clarification using depth filtration and continuous flow centrifugation and host cell protein reduction during cell culture.
  • Experience with phase-I process development, DOE studies, development of process control strategies. Familiarity with JMP or similar statistical software.
  • Demonstrate advanced ability to collaboratively solve complex problems aligned with strategic program goals.
  • Superior oral and written communication skills.

 

 

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