GMP Associate Scientist
12-16 month contract
Years Experience: 2 years minimum
Location: DHVI in Durham, NC - need someone local!
$35-40 an hour
Occupational Summary
The Associate Scientist I 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.
Work Performed
- Perform Upstream and/or Downstream 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
- 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.
- 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 and analytical development functions to understand how the production process is impacts 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 and present results.
- Write and reviews technical development reports; assist with writing protocols for tech transfer and SOPs for GMP production, and present data to project teams and larger settings.
Education/Training:
Bachelor's degree in a science, engineering, or related field
