Senior Research Investigator, Purification Process Sciences

Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function): Incyte Corporation is seeking a motivated and experienced protein purification scientist to provide technical expertise in monoclonal antibody (including bispecifics) purification process development, characterization, and validation primarily for novel therapeutic monoclonal antibody products throughout all stages of clinical trials and commercialization. Essential Functions of the Job (Key responsibilities): Lead purification process development including viral clearance studies, scale-up, and technology transfer to CMO or internal manufacturing facility Participate in BLA-enabling purification process characterization and validation studies Perform analysis of in-process samples using relevant product purity and process impurity analytical tools as needed Write development, characterization, validation, and tech transfer reports Present updates in routine cross-functional project team meetings Participate in critical review of manufacturing batch records and deviations Participate in writing and reviewing the CMC sections of IND and BLA documents Other responsibilities as needed Qualifications (Minimal acceptable level of education, work experience, and competency): PhD in biochemistry, bioengineering, biology, chemistry or related fields with a minimum of 5 years of relevant industry experience or a MS degree with a minimum of 8 years of relevant industry experience Fundamental knowledge in protein chemistry, bioprocessing, and cGMP Fundamental knowledge and hands-on experiences in various types of column/membrane chromatography (affinity, size exclusion, ion exchanges, multi-mode) and filtration technology (depth filtration, TFF, and nanofiltration) Experiences in purification process development, characterization, and validation for manufacturing biologics drug substances Experiences in purification process viral clearance studies Experiences in purification process scale-up and technical transfer to manufacturing Experiences in using AKTA line of purification instruments from lab scale to pilot scale Excellent verbal and written communication skills Experiences in Design Of Experiment methodology, in interactions with regulatory, QA, QC, and CMO, and in writing CMC section of IND and BLA documents will be preferred Disclaimer:

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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