GMP, SCIENTIST/ENG-2, BIOPROCESS

Job description

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.

Scientist II, GMP Bioprocess Development (Downstream)

Duke Human Vaccine Institute (DHVI)

Role Summary

The Scientist II 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

  • Lead Downstream aspects of lab scale process development and GMP production including:
  • Downstream techniques
  • Chromatography development: Resin screening (IEX, HIC, Mix-Mode, Affinity, SEC), optimization, and robustness testing.
  • Filtration Development: Development of various filtration techniques including ultrafiltration/diafiltration, depth filtration, viral filtration, sterile filtration.
  • GMP Production: Process scale up, tech transfer, and execution of the process under GMP conditions.
  • Utilize a broad expertise in bioprocess development and external expertise (vendors, publications) to develop a comprehensive strategy for overall development effort of various candidates with the goal of reducing development cycle times and improving process robustness.
  • Lead collaboration with other development teams to provide support for development activities and will work diligently with cell line, upstream and analytical development functions to understand how the process impacts product quality.
  • Analyzes and interprets data and results of individual and team work, utilizing the data in appropriate decision making; summarize data and present results.
  • Leads writing and 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.
  • Identifies and documents innovations including patenting and publishing of scientific results.
  • Mentors and develops junior staff.
  • 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: 10 years relevant experience in the biopharmaceutical industry or equivalent.

    Preferred Education, Experience, and Skills

    • 10+ years relevant experience in the biopharmaceutical industry or equivalent.
    • Experience in development of protein and/or virus purification techniques; experience leading implementation of bioprocess unit operations (Chromatography, TFF filtration, GE Unicorn software) and/or direct GMP experience is required
    • Demonstrates innovation in downstream purification (chromatography, tangential flow filtration, normal flow filtration) and analytical techniques to support development activities (SDS-PAGE, western blot, SEC, UV-Vis).
    • Must work independently to develop specific processes or methods in line with strategic program goals.
    • Demonstrated advanced ability in solving complex analytical problems in alignment with strategic project plans.
    • Superior oral and written communication skills
    Minimum Qualifications

    Education

    Bachelor's degree in a science, engineering, or related field. An advanced degree (Master's, PhD) is preferred.

    Experience

    10 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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    Job No:
    Posted: 9/8/2020
    Application Due: 12/17/2020
    Work Type:
    Salary: