Associate Scientist, Analytical Development - On-site, Philadelphia, PA

Reporting to Director, Analytical Development, this experienced and motivated Associate Scientist will join Analytical Development Team, participating in a variety of analytical activities involved in lifecycle method management - method development and qualification, analytical testing support for projects at Process Development and CDMOs, CDMO testing oversight (assay performance trending, troubleshooting/root cause analysis) for pre-clinical and clinical programs. Responsibilities: Participate in the development, optimization, and qualification/validation of analytical methods, as required to evaluate safety, purity, identity, potency of lentiviral vectors, cell therapy product and other advanced modalities, in compliance with relevant regulatory guidelines Perform analytical testing, supporting method development and qualification activities. Participate in technical oversight and serve as subject matter expert (SME) to CDMOs and external laboratories. Assist monitoring/trending of assay performance, investigation of assay deviations, out-of-specification, out-of-trend and out-of-expectation results at Analytical Development and external partners. Provide analytical expertise to Process Development, Manufacturing Sciences and Technology (MSAT), Quality & Compliance, and Quality Control Author and review method protocols, reports, and supporting documentation, ensuring compliance with GMP, GDP, and applicable regulatory requirements. Present in technical meetings and drive resolution of analytical-related issues. Qualifications: