GMP, SCIENTIST/ENG-2, BIOPROCESS
School of Medicine:
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Scientist II, GMP Bioprocess Development (Downstream)
Duke Human Vaccine Institute (DHVI)
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.
- 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.
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
Bachelor's degree in a science, engineering, or related field. An advanced degree (Master's, PhD) is preferred.
10 years relevant experience in the biopharmaceutical industry or equivalent.
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