Senior Scientist - Analytical Development

The Senior Scientist will play a key role in the development, optimization, transfer, qualification, monitoring, and execution of molecular analytical methods supporting gene therapy process development and/or Manufacturing. This individual will provide technical expertise across early- through late-stage programs, ensuring analytical strategies are scientifically sound, phase-appropriate, and aligned with regulatory expectations. The role includes assay design, troubleshooting, data interpretation, method lifecycle management, and cross-functional collaboration with Process Development and/or Manufacturing, Quality, and GMP testing teams to advance program goals.

Primary Responsibilities: Lead and execute molecular method development, optimization, transfer, qualification, monitoring, and lifecycle management to support gene therapy process development/manufacturing and transfer to GMP testing. Design, perform, and interpret complex experiments with minimal supervision to evaluate vector genomes and related molecular attributes using nucleic acid–based technologies (qPCR, dPCR, ddPCR). Provide robust in-process analytics and product characterization support for analytical assays that support Process Development and/or Manufacturing, including support of investigations and technical troubleshooting.

Generate, analyze, trend, and interpret high-quality data; clearly communicate findings and recommendations to cross-functional stakeholders. Author and review technical reports, protocols, summaries, and source documentation in compliance with GMP standards and to support regulatory submissions. Present data and project updates at cross-functional meetings and contribute to scientific discussions and decision-making.

Support analytical method qualification activities, continuous improvement initiatives, and data review processes to ensure scientific rigor and regulatory alignment. Maintain laboratory instrumentation, ensure proper documentation practices, and oversee organization of reagents, materials, and laboratory records in accordance with quality standards. Work with molecular assays as a primary responsibility and, as needed, support analytical testing across additional assay platforms (e.g., cell-based, potency, or ELISA assays) to meet program and project needs.

Education, Experience, & Qualifications: Bachelor’s or Master’s degree in Molecular Biology, Biochemistry, Cell Biology, Immunology, or related discipline with 6–10 years of relevant industry experience, or a PhD with 3–5 years of industry experience preferred. Demonstrated experience in development, optimization, transfer, and execution of molecular analytical methods, particularly PCR-based assays (qPCR, dPCR/ddPCR) for nucleic acid quantification and characterization. Experience supporting gene therapy programs, including molecular assays for vector genome titer, residual DNA analysis, and other nucleic acid–based characterization methods.

Strong expertise in assay troubleshooting, experimental design, and data analysis to support process development, method qualification, and product characterization. Familiarity with GMP documentation practices, including preparation of technical reports, protocols, test methods, and data review to support regulatory and quality expectations. Excellent attention to detail, scientific communication, and cross-functional collaboration skills, with the ability to manage multiple priorities in a fast-paced environment. #J-18808-Ljbffr