The primary goals of Analytical Sciences are: to lead the phase-appropriate optimization, qualification, verification and validation of analytical methods across the product development lifecycle from clinical to commercialization; provide support to QC in the investigation of non-conformances, invalid assays; and troubleshooting method problems. Analytical sciences will also be responsible for developing and overseeing a critical reagents management program, the reference standard program, periodic review of analytical methods, and method performance trending and monitoring.
Reporting to the QC BioAssay and Cell Culture Lead, s/he is responsible for optimizing, qualifying and maintaining assay specific Critical Reagents and compound specific Reference Standards. The role will also support Analytical Sciences Departmental goals by participating in development, optimization, qualification and validation of analytical assays within the Technical Operations Analytical Sciences organization at Spark Therapeutics’ facility in Philadelphia, PA.
• Optimize, qualify and maintain inventory of Reference Standard and Critical Reagents used in Quality Control.
• Create technical protocols and reports for Critical Reagents.
• Trend and report method and Critical Reagents performance data
• Provide support to QC investigations through experimental design, data mining and analysis, problem solving and technical writing
• Execute experiments in support of Bioassay method development and optimization, with guidance from internal management
• Participate in Cell-based method qualification/validation and method transfer studies...cont.