Senior Scientist, Engineering- Cell Banking

Senior Scientist, Engineering
- Cell Banking Skip to main content
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- Cell Banking page is loaded## Senior Scientist, Engineering
- Cell Banking Apply remote type:
Not Applicable locations:
USA
- Pennsylvania
- West Pointtime type:
Full time posted on:
Posted Todaytime left to apply:
End Date:
August 14, 2026 (14 days left to apply) job requisition :
R410063
** Job Description
** Our Scientists and Engineers support internal development and internal/external manufacturing operations to remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Scientists have opportunities across many diverse areas including Biological, Chemical, Automation, Safety, Technical Services, Process Development, Analytical, Regulatory, and Quality.
As part of Our Company’s Manufacturing Division, within the Biologics Drug Substance Commercialization (BDSC) organization, the upstream process science and technology department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. The group supports various cell bank and upstream drug substance process commercialization activities and second generation process development including cell banks, process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.
Under the general scientific and administrative direction of Director, Engineering, and working in conjunction with internal and external partners, this person will support mid-late stage and commercial cell bank-related projects for large molecule programs. The person will be responsible for commercialization activities on late-stage pipeline and/ or post-market commercial manufacturing working cell banks for biologics and/or vaccines. Activities include cell bank process assessments and transfers, manufacturing investigations and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on standardization across programs.  

Technical scope:
* Direct projects focusing on cell bank process risk assessments, documentation, process characterization, technology transfer and qualification of new cell banks with line-of-sight for licensure and commercialization.
* Responsible for planning and executing work to support commercialization of working cell banks, identification and implementation of process changes for replenishment lots, control strategies, manufacturing operations, investigation evaluations, and regulatory filings.
* Design, plan, and execute laboratory experiments to generate high quality data.  Perform data analysis and ensure results are reported clearly and accurately and effectively communicate study results to stakeholders via presentations and technical reports.
* Collaborate with research and commercial teams to deliver process documentation packages, review batch records, support technology transfer activities, and provide investigation support for cell bank manufacturing, both within our Company network and at contract manufacturing organizations (CMOs).
* Author required regulatory and technical documentation associated with cell bank process transfer, long term storage stability,…