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The Formulation Scientist is responsible for formulation development of antibodies and other reagents to establish new methods for analyzing and improving product stability and delivery. This will include, but not be limited to: (1) development, testing and troubleshooting of antibody and other protein formulations, (2) development of lyophilization procedures, (3) selection of containers, closure methods and storage conditions, (4) stability studies and (5) optimization of surface coating.
· Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemistry, or a related field is required.
· Minimum of 3 plus years of experience in pharmaceutical, diagnostics or related industry as well as experience in a commercial manufacturing or contract manufacturing company
· Hands–on knowledge and experience in protein chemistry, formulation and lyophilization.
· Thorough understanding and experience in the development of protein, proficient in developing tests and methods to improve reagent quality and stability.
· Knowledge and experience with Design of Experiments (DOE).
· Experience in GLP or cGMP setting is highly desirable.
· Qualified candidates must be well versed in the regulatory documentation as related to reagent manufacturing and QC.
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