ELISA Scientist

General Description:Perform testing in support of product manufacturing, employing manual and automated analytical equipment. Provide direct support of Quality Control analytical processes, test procedures, qualifications, validations, assay troubleshooting, equipment upkeep, logbook review, and inventory control.Job Responsibilities:Execute Analytical Test Methods for in-process samples, bulk intermediate (drug substance), final drug product, and raw materials release, as well as stability testing.Primary testing responsibility will be conducting ELISA testing to support assays such as Residual p24, COL7/Lam332, BSA, and Trypsin assays. However, cross-training in cell culture and other analytical methods will be required (e.g. qPCR, flow cytometry platforms).Coordinate, schedule, and execute testing based on manufacturing schedules.Participate in the review process of SOPs and analytical test procedures as necessary to maintain compliance.Review Quality Control raw data for accuracy, completeness and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product.Troubleshoot and analyze nonconforming data.Perform timely response to Out of Specification (OOS) results, including notification to area management. Perform and document laboratory investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented. Execute associated CAPA.Ensure data integrity is maintained for all applications, programs, and executed work. Ability to document all work using Good Documentation Practices and ALCOA principles.Maintain laboratory housekeeping including organization, cleanliness, and logbooks.Perform internal audits and GEMBA walk-throughs of laboratory areas to maintain compliance.Author and/or execute protocols and generate technical reports.Author and manage change controls.Perform equipment standardizations and qualification, as necessary.Perform training of other employees.Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule.