Associate Scientist, Analytical Development

Position Summary

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. The successful candidate has opportunities to collaborate closely with CMC, Quality & Compliance, Supply Chain, and external partners.

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

• Bachelor's or master's degree in biology or closely related discipline with 2-4 years of experience
• Proficient in aseptic techniques for cell culture and cell-based assays
• Strong experience in analytic techniques, including flow cytometry, qPCR/dPCR, ELISA, HPLC etc.
• Demonstrated experience with analytical method qualification and validation
• Experience working with CDMOs and contract testing laboratories in biologics, cell and gene therapy fields
• Familiar with GMP compliance
• Demonstrated scientific problem-solving, critical-thinking, and communication/interpersonal skills, with attention to detail and strong organizational skills, and ability to manage multiple priorities in a fast-paced environment