Job Details

Occupational Summary

The Associate Scientist I will support the development, qualification, and execution of analytical methods to enable optimization of processes, formulations and characterization of vaccine products. This incumbent in this position will be involved in pharmaceutical and analytical development for GMP production of vaccine products and therapeutics.

Work Performed

• Perform pharmaceutical development and successful GMP release including:
  • Analytical development
  • Develop product specific release and characterization methods
• Quality methods for product release and complete comprehensive characterization of clinical lots
• Complete GMP testing in line with OCH and regulatory guidance
• Formulation development – developing formulations to stabilize vaccine products
• Employ analytical characterization tools to inform product formulation design
• Lead formulation & filling of vaccine products including tech transfer & production under GMP conditions
• Execute and document development and GMP actitivites in compliance with regulatory requirements
• Collaborate closely with other development teams to provide support for development activities and will work diligently with other 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 date, present results and propose next steps to advance development
• Write and review development reports; writes procols for tech transfer and SOPs for GMP production, and present data to project teams and larger settings

Required Qualifications

• Education: bachelor’s degree in a science, engineering, or relate field
• Skills:
  • Knowledge and hands on classwork with analytical methods and/or product formulation
  • Hands on experience with specific analytical methods (HPLC, immunoassays, biochemical methods), molecular or pharmaceutical product formulation (buffer & excipient screening, thermal stability evaluation, biophysical methods) is preferred.
  • GMP experience huge plus
  • Must have the ability to work independently with guidance from senior scientists/managers
  • Demonstrated ability in solving moderately complex analytical problems with guidance from senior development scientists
  • Strong oral and written communication skills