Senior Analytical Scientist
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. If you are looking to be part of a highly technical environment with opportunities for growth and new challenges, this role may be the perfect fit for you!
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.
- 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.
- Work with molecular assays as a primary responsibility and, as needed, support analytical testing across additional assay platforms
Education/ 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
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