GMP, Associate Scientist/Engineering-2, Bioprocess
Duke Human Vaccine Institute - Admin
The Associate Scientist II will support 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.
- Perform 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.
- Downstream techniques
- Design experiments, execute and document development and GMP activities in compliance with regulatory requirements.
- Support CGMP production, including equipment and material management, to ensure facilities and materials meet DHVI needs, perform investigations.
- Provide support for cGMP campaigns, including documentation, deviation and root cause analysis.
- Collaborate closely with other development teams to provide support for development activities and will work diligently with cell line development, upstream development, and analytical development functions to understand how the production process changes impact product quality.
- Compile data and perform analysis and interpretation and draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making; summarize data, present results and propose next steps to advance development.
- Write and reviews technical development reports; writes protocols for tech transfer and SOPs for GMP production, and presents data to project teams and larger settings.
- Supports innovations including patenting and publishing of scientific results.
- 4+ years relevant experience in the biopharmaceutical industry or equivalent.
- Experience in downstream purification development (chromatography, tangential flow filtration, normal flow filtration, GE Unicorn Software) and analytical techniques to support downstream activities (SDS-PAGE, western blot, UV-Vis, colorimetric methods). Direct GMP experience is a plus.
- Experience with nucleic acid purification is a plus.
- Must have the ability to work independently to develop specific processes or methods with limited guidance from senior scientists/managers.
- Demonstrated ability in solving complex analytical problems with guidance from senior development scientists.
- Strong oral and written communication skills.
Requisition Number 401464827
Duke Entity MEDICAL CENTER
Job Code 3004 GMP, ASSOC SCIENTIST/ENG-2, BIOPROCESS
Job Family Level 86
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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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.
Bachelor's degree in a science, engineering, or related field. A Master's degree is preferred.
4 years relevant experience in the biopharmaceutical industry or equivalent.
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