at Incyte Corporation in Wilmington, Delaware, United States
Responsible for leading Incyte’s biologics pipeline that includes monoclonal or bispecific antibodies, fusion proteins, and other large molecules in early to late-stage clinical development, as well as commercial launch. Executes early and late-stage cell culture process development and optimization, scale up, process characterization and validation activities. Leads technology transfer and clinical manufacturing activities towards development and commercialization of pipeline molecules. Author and/or review CMC sections for regulatory submission of pipeline molecules. Work as a subject matter expert to support Incyte GMP manufacturing group or a CMO/ CRO for process transfer, Including troubleshooting and process risk analysis. Author or review technical reports, deviation reports and manufacturing investigations, standard operating procedures, process description, batch records. guideline documents, CMC sections of regulatory document and tech-transfer documents. Serve as person-in-plant during key manufacturing activities to drive the development of pipeline molecules leading to commercialization, ensuring successful process transfer and/ or management of CMO/ CRO activities. Collaborates closely with Incyte CMC and process cross-functional teams. which includes project management, purification, analytical, and formulation, as well as quality assurance and regulatory teams, to support batch release. manufacturing investigations, and risk analysis. Manage laboratory supplies and equipment maintenance. Make presentations to internal functions and external partners as a part of development and commercialization of pipeline molecules. Takes leadership in promoting technology development and continuous improvement to streamline biologics development in Incyte.
EDUCATION & EXPERIENCE: Master's degree or foreign equivalent in Chemical Engineering, Biochemical Engineering, Biochemistry, Cell Biology, Pharmacology, Toxicology or related field and 7 years of experience in job offered or related occupation. Alternatively, the employer will accept a Doctorate degree and 4 years of experience in lieu of Master's degree and 7 years.