Principal Investigator, Purification Process Scien

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

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.
Our Global BioPharmaceutical Group 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.
Job Responsibilities:
lead purification process development including viral clearance studies, scale-up, and technology transfer to CMO or internal manufacturing facility
Lead BLA-enabling purification process characterization and validation studies
Lead routine analyses of in-process samples using relevant product purity and process impurity analytical tools
Write development 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 assigned
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, HIC, multi-mode) and filtration technology (TFF and nanofiltration) for cell culture harvest and clarification, protein purification and analysis
Experiences in protein purification process development, characterization, and validation for manufacturing biologics drug substances
Experiences in using UF/DF instrument for buffer exchange, product concentration, and formulation
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
Experiences in using analytical instruments for protein analysis such as HPLC, CGE, light scattering, etc.
Excellent verbal and written communication skills
Cooperative, independent, capable of critical thinking and multi-tasking
Experiences in Design Of Experiment methodology, in interactions with regulatory, QA, QC, and CMO, and in writing CMC section of IND and BLA documents

We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.        

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Job Posting: 995225

Posted On: Jun 29, 2022

Updated On: Jul 29, 2022