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Senior Scientist, GMP Bioprocess Development Product Line Manager

Work Arrangement: 
Requisition Number:  190824
Regular or Temporary:  Regular
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER
Date:  Aug 7, 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 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.

GMP Bioprocess Development Senior Scientist, Product Line Manager

Duke Human Vaccine Institute (DHVI)

 

Role Summary

 

The Process Development Senior Scientist will serve as a product technical leader to oversee upstream development activities and expressed protein related projects.  They will provide deep expertise to afford sufficient technical oversight in these specific areas to enable development of sufficient processes in support phase I manufacture of novel immunogen constructs.  In this role the Senior Scientist will lead upstream development (e.g., cell culture, fermentation, etc.) and collaborate with other product leads and supporting teams to derive the next generation of immunogens for HIV, influenza, and emerging diseases such as coronaviruses.  This role will define quality target product profiles for each vaccine construct, maintain technical readiness dashboards, and derive comprehensive empirical plans leveraging strategic historic knowledge and alignment with manufacturing capabilities.  They will also define the work package scopes and coordinate empirical execution across upstream development in collaboration with other process development teams, as well as analytical and GMP-Operations teams.  The Senior Scientist will serve as the primary subject matter expert where they will present findings to both internal and external sponsors, provide technical guidance, and facilitate technical transfer throughout the process development lifecycle, in particular in collaboration with the GMP-Operation teams.  The role will also identify and enable capability gaps, as well as, foster innovation within process development and GMP-Operations to enable phase I manufacture of novel immunogen constructs.   

 

Responsibilities

  • Lead upstream development and expressed protein projects with other product line leads to derive the next generation of immunogens (30%)
  • Facilitate technical transfer throughout the process development lifecycle in collaboration with the GMP-operation team (20%)
  • Coach and mentor upstream staff scientist (10%)
  • Identify and enable capability gaps and foster innovation within process development and internal GMP-Operations (10%)
  • Compile pivotal results and draft and present coherent and cohesive communication packages to foster understanding and derive collaborative decisions with sponsors and the GMP organization (10%)
  • Ensure good documentation practices within the electronic notebook, inventory systems, and so on (10%)
  • Oversee collaborative drafting of technical development reports and process technical transfer documents (10%)

 

Education and Experience

  • Bachelor’s degree in a science, engineering or related field; an advanced degree (Master's or PhD) is preferred
  • 13 years relevant experience in the biopharmaceutical industry or equivalent
  • GMP experience is required

 

Required 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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