General Responsibilities: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.Position Details:Execute Analytical Test Methods for bulk intermediate (drug substance), final drug product, and raw materials release/stability testing. Primary testing responsibility will be conducting DNA extraction and qPCR testing to support Vector Copy Number (VCN) Castle Creek Biosciences is an Equal Employment Opportunity Employer
and Vesicular Stomatitis Virus G glycoprotein (VSVG) assays. However, cross-training in cell culture and other analytical methods will be required (e.g. ELISA, Flow Cytometry)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 of 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