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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.

GMP Bioprocess Development Senior Scientist, Product Line Manager

Work Arrangement: 
Requisition Number:  204814
Regular or Temporary:  Regular
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER
Date:  Jan 12, 2023

This Position is 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 lead and oversee downstream development activities.  They will provide deep expertise to afford sufficient technical oversight in these areas to enable efficient development of processes to support phase I manufacture of novel immunogen constructs.  This role involves collaborative technical leadership across process development and supporting teams to derive GMP scalable processes for the manufacture of next generation vaccines for HIV, influenza, and emerging diseases such as coronaviruses.  This involves fostering biomolecular design of expressed constructs to enable efficient downstream purification development, derivation of empirical plans and execution oversight, and coordinate of efficient analytical assessments to facilitate accurate and informative collaboration discussion with various internal and external stakeholders.   Drafting process and product design intents that include the quality target product profile (QTPP) definition, as well as sustainment of technical readiness dashboards, risk assessments and technical transfer throughout the process development lifecycle are also commensurate to this role.  The Senior Scientist will serve as the primary subject matter expert for downstream process development and as a product line lead for expressed immunogen constructs.  The Senior Scientist will also identify and enable capability gaps and foster innovation within both process development and the GMP manufacturing suites.   

 

Responsibilities

 

 

Education and Experience

  • Bachelor’s degree in a science, engineering or related field; an advanced degree (Master's or PhD) is preferred
  • 13 years of relevant experience in the biopharmaceutical industry or equivalent
  • A Master or PhD is preferred and with GMP experience
  • Background in risk assessment or lean sigma is preferred
     

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.

 


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh