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 a motivated a Senior Manager, Biologics US External Manufacturing to support successful operations of cGMP manufacture of recombinant monoclonal and bispecific antibodies at diverse group of US contract manufacturing organizations (CMO) from Phase 1 through commercial manufacture. The Senior Manager is responsible for GMP manufacture activities including upstream mammalian cell culture, downstream purification, and sterile vial fill finish in collaboration with functional area SMEs, Project Management, and Quality Assurance. The position supports all activities occurring at CMOs related to manufacturing, which can include but is not limited to, project management, document readiness, coordination of internal manufacturing teams, batch release support, investigations, validation activities, and budget management. This position will report to the Director, Biologics US External manufacturing.
Essential Functions of the Job (Key responsibilities)
Manage detailed project plans with CMO project lead to ensure clarity and attainment of milestones and timelines; develop mitigation plans as needed to achieve project deliverables.
Identify issues and facilitate problem solving, contingency planning, and decision-making.
Coordinate with Incyte PM to secure manufacturing capacity and maintain manufacturing timelines.
Perform Project Manager role in Manufacturing capacity sharing collaboration with Incyte partner.
Ensure timely review and approval of manufacturing documents i.e. Executed Batch Records.
Manage Manufacturing investigations with Quality Assurance and seek SME input as needed.
Inform key stakeholders of project status, and existing or potential issues and propose solutions as appropriate.
Partner with Project Team Leader of the CMOs to foster effective team dynamics; routine interaction assessing progress of the programs and presenting to the team.
Plan and manage the execution of process validation protocols for biopharmaceutical manufacturing processes.
Provide engineering support to manufacturing process to improve efficiency, sustain product quality, and reduce cost of goods.
Review and assess agreements from technical & management point of view.
Manage budget for CMO Activities.
Plan with Clinical and Commercial Supply Chain to ensure sufficient MFG capacity is reserved to avoid stock out.
Coordinate product, intermediates, and samples shipments with CMOs.
Support Technical Transfer from a CMO and facilitate TT from GBD to CMO as needed.
Perform as Person-in-Plant (PIP) in manufacturing campaigns.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS/MS in Biology, Biochemistry, Chemical Engineering or related Life Sciences field.
5-10 years of experience in GMP Manufacture and/or Technology Transfer of Biological (i.e. monoclonal antibodies) products preferably with a protein purification focus.
Experience leading and managing projects, either as an SME or PM.
Excellent verbal and written communication skills required.
Good inter-personal skill to work with regulatory, QA, QC, CRO, and CMO.
Cooperative, independent, capable of critical and strategic thinking and multi-tasking.
Experience in preparing and reviewing CMC documentation for regulatory filings to support global regulatory submissions from IND to BLA as well as regulatory inspections.
Travel required, as needed.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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