Principal Research Scientist (Bloomington,IL) - (Bloomington, IL)

The Analytical R&D department at AbbVie is seeking an experienced senior scientist, group leader preferably with ability in the areas of process analytical, CMC, regulatory filings and pharmaceutical sciences. The individual will be responsible to lead the analytical support of API development and commercialization while working with other functional areas to advance projects through the pipeline. Responsibilities: Background in leading cross-functional teams focused on drug substance control strategy and specification setting across all stages of API development. Sound understanding of overall CMC development. Ability in analytical method development and validation, method transfer in a cGMP environment. Background in working with CRO and CMO is highly preferred. Familiar with API control strategy, regulatory starting material (RSM) justification and mutagenic impurity (MI) assessment. Background in filing IND/IMPD. Filing background on NDA and/or MMA is not a must but considered as a plus.