Our client has an immediate opening for a lead Scientist to join the Protein Biochemistry group.

Job Responsibilities:

This individual will be responsible for leading analytical development activities in support of early and late phase/commercial protein therapeutic products. This position involves method development of characterization assays used for regulatory filings as well as provide analytical support for the manufacturing process. He/She should be highly motivated, able to work in a team environment and will supervise the activities of other Associates.

Requirements:

• A Ph.D. in Biochemistry or a related discipline

• A minimum of 5 years of industrial experience.

• Must provide expertise in characterizing protein therapeutic products utilizing, but not limited to HPLC, Mass Spectrometry, SDS-PAGE, ELISA and analysis of carbohydrates.

• Must be very experienced with cGMP and be familiar with FDA, EU, and ICH regulations.

• Experience with assay validation is beneficial.