at Incyte Corporation in Wilmington, Delaware, United States
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 Development Group is looking for an experienced upstream process development scientist to lead upstream bio-processes development and optimization. This role will be 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. The responsibilities include process development and optimization, scale-up, technology transfer, process characterization, and validation. As necessary, he/ she will be required to author/ review CMC sections for regulatory submission, work as a subject matter expert to support Incyte GMP manufacturing group or a CMO/ CRO for process transfer, troubleshooting, batch record/ report reviews, 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. The individual is expected to multi-task on several projects running simultaneously.
Essential Functions of the Job (Key responsibilities)
Executes early and late-stage cell culture process development, scale up, process characterization and validation activities as necessary.
Leads technology transfer and clinical manufacturing activities towards development and commercialization of pipeline molecules.
Serves as a person-in-plant during key manufacturing activities to drive development of pipeline molecules leading to commercialization.
Author or review or assist authoring CMC sections for regulatory submission of pipeline molecules.
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.
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.
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.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Ph.D. degree in Chemical Engineering, Biochemical Engineering, Biochemistry or Cell Biology with 4+ years of experience or Master's degree in Chemical Engineering, Biochemical Engineering, Biochemistry or Cell Biology with 7+ years of experience working in cell culture process development/ manufacturing support in a biopharmaceutical industry.
Experience with cell culture process development, technology development, scale-up, technology transfer, design of experiments, bioreactor culture, troubleshooting, authoring and review of batch record and technical report is essential.
Experience of working on several projects running simultaneously while working independently as well part of a team is essential.
Some experience with authoring and/ or review of CMC sections for regulatory submission is required.
Experience with cell line development, bioprocess automation, process characterization, validation and process risk analysis is preferable.
Experience in GMP cell culture manufacturing operations or manufacturing support is beneficial.
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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