Incyte Wilmington , DE 19801
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development, and commercialization of proprietary therapeutics, primarily for oncology. Our first commercial product, Jakafi, is approved in the U.S. for patients with intermediate or high-risk myelofibrosis and for patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. We have a diverse and growing portfolio of product candidates, including both small and large molecules.
Our Biologics Product and Process Development group is seeking an experienced cell culture scientist to develop and optimize early and late phase bio-processes in support of Incytes biologics pipeline that includes monoclonal antibodies, fusion proteins, and other large molecules in early to late stage clinical development as well as commercial launch. The individual will be responsible for early and late phase cell culture process development which includes process development and optimization, manufacturing support, troubleshooting, process characterization, and validation. As necessary, he/ she will be required to work with Incyte GMP manufacturing group or a CMO/ CRO for process execution, troubleshooting, batch record reviews, reports, process risk analysis, and manufacturing investigations. The individual may be needed to be a person-in-plant to assist in successful process transfer and/ or management of CMO/ CRO activities for pipeline molecules. The individual will work directly with Incyte CMC and process teams, which includes project management, purification, analytical, and formulation. On occasions, he/she may be needed to assist quality assurance and regulatory team members. The individual is expected to multi-task on several projects running simultaneously.
Executes experiments to support early and late-stage cell culture process development, scale up, characterization and validation activities as necessary.
Assist in technology transfer and clinical manufacturing activities towards development and commercialization of pipeline molecules.
Serves as a person-in-plant during key manufacturing/ development activities in a contract manufacturing/ research facility to drive development of pipeline molecules leading to commercialization.
Author or review technical reports, deviation reports and manufacturing investigations, standard operating procedures, process description, batch records, guideline documents and tech-transfer documents.
Collaborates closely with cross-functional teams like purification, analytical and formulation, as well as QA and regulatory, to support batch release, manufacturing investigations, and risk analysis.
Make presentations as necessary 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.
Communicates clearly and collaborate actively with internal cross-functional teams to facilitate pipeline development of large molecules.
Ph.D. degree, Masters degree or Bachelors degree in Chemical Engineering, Biochemical Engineering, Biology, Molecular Biology, Biochemistry or Cell Biology.
1- 5 years of experience working in cell culture process development/ manufacturing support in a biopharmaceutical industry.
Hands-on experience with cell culture process development, manufacturing support or GMP manufacturing, troubleshooting, authoring and review of batch record is essential.
Previous experience of working on several projects running simultaneously while working independently as well part of a team is essential.
Experience with cell line development, scale-up, technology transfer, design of experiments, bioreactor culture, bioprocess automation, process characterization, validation and process risk analysis is preferable.
Experience in GMP cell culture manufacturing operations or manufacturing support is beneficial.
Previous experience with authoring and/ or review of CMC sections for regulatory submission is beneficial but not necessary.