GMP Associate Scientist I, Bioprocess - 157150

Role 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.  

Responsibilities

• Perform Upstream and/or Downstream aspects of lab scale process development and GMP production including:
• Upstream techniques
  • Media, feed and buffer preparation
  • Cell culture development (ex. CHO, 293, insect cell)
  • Growth media selection and optimization 
  • Derivation and characterization of stable cell lines
  • Preparation and operation of bioreactors
  • mRNA platform development

• 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.
• Provide support for cGMP campaigns, including documentation, deviation and perform investigations (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.

Experience/Skills

• Knowledge and hands on classwork with cell culture and basic analytical techniques; hands on implementation of bioprocess unit operations (bioreactor control and operation, harvest and clarification) and/or direct GMP experience is preferred
• Experience in upstream (cell culture, bioreactor operation including scale up) and basic analytical techniques to support upstream activities (cell and metabolite analyses, SDS-PAGE, western blot, UV-Vis).