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Manager, GMP (Upstream Development Group Leader)

Req ID:  4879
Date:  Nov 3, 2019
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER

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.

 

Manager, GMP (Upstream Development Group Leader)  

Duke Human Vaccine Institute (DHVI)

 

Role Summary

 

The Manager, GMP (Upstream Development Group Leader) is responsible for planning, organizing and overseeing the day to day activities relating to the development of new vaccines and clinical therapeutic candidates. 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. The incumbent will work closely with other area managers and senior management to deliver optimized strategies suitable for the cGMP manufacture of innovative vaccine candidates and ensure scientific rigor during execution of cGMP campaigns.  

 

Responsibilities

 

  • Thought leader who envisions new processes and methods for development. 
  • Lead Upstream aspects of lab scale process development and GMP production including:
    • Upstream techniques
      • Cell culture development (ex. CHO, 293, insect cell)
      • Growth media selection and optimization 
      • Derivation and characterization of stable cell lines
  • Organizes, manages and oversees technical work of a specific organization unit or technical area.
  • Develops work plans, assigns & prioritizes work according the program needs and team skill set.
  • Mentors others in developing scientific skills and methods and may manage staff.    
  • Consults management for strategic direction and focus. 
  • Leads review of technical development reports; writes and reviews protocols for tech transfer and SOPs for GMP production, and presents data to project teams and larger settings.
  • Presents extensively at external meetings and/or management forums. 
  • Develops patents and publications to protect IP and advance the field.

 

Preferred Education

 

  • Bachelor’s degree in a science, engineering, or related field.  Advanced degree MS/PhD is highly preferred.

 

Preferred Experience/Skills

 

  • 8+ years of years of experience in the biopharmaceutical or bioprocess industry or equivalent is required with direct experience in process development.  Previous direct or indirect supervisory experience is a plus.
  • Relevant knowledge and industrial experience in the field of bioprocess development for manufacture of biomolecules and vaccines and experience in transferring processes to cGMP facilities for clinical or commercial manufacture. 
  • Skill and experience with key bioprocess techniques including; cell culture, cell line development, bioreactor operation and scale-up, centrifugation, tangential flow and normal flow filtration.  Expertise in biomolecule (protein, mRNA, DNA) characterization is a plus.     
  • Experience with successfully seeing a product through process development and GMP production for early Phase I/II clinical trials.

 

Minimum Qualifications

 

Education

 

Bachelor's degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.

 

Experience

 

8 years of experience in the biopharmaceutical or bioprocess industry or equivalent is required with direct experience in process development. Previous direct or indirect supervisory experience is a plus.

 

Duke University 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 essential job 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