Senior Scientist - Analytical Development

Job Description

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.