GMP, ASSOC SCIENTIST/ENG-1, ANALYTICS

Duke Careers•Durham, NC

5d•Onsite

About The Position

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.

Requirements

Generally requires a bachelor's degree in a science, engineering, or related field.
None

Nice To Haves

Responsibilities

Perform pharmaceutical development and successful GMP release including: Analytical development
Develop product specific release and characterization methods
Qualify methods for product release and complete comprehensive characterization of clinical lots.
Complete GMP testing in line with ICH and regulatory guidance.
Formulation development
Develop formulations to stabilize vaccine products.
Employ analytical characterization tools to inform product formulation design
Lead formulation & filling of vaccine products including, tech transfer and production under GMP conditions.
Execute and document development and GMP activities 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 data, present results and propose next steps to advance development.
Write and reviews development reports; writes protocols for tech transfer and SOPs for GMP production, and presents data to project teams and larger settings.