Description
Join our Cell Therapy Analytical Development team, where we develop and deliver robust, technologically advanced biological assays to progress cell therapy products from research to commercial stages.
Our team supports the end-to-end biological and bioanalytical characterization of viral vector and cell therapy products, enabling manufacturing processes, formulation, drug product development, and regulatory filings from IND to BLA and beyond. We collaborate closely with analytical quality and several cross-functional teams, including clinical, regulatory, QA, and manufacturing.
Key responsibilities include:
- Developing robust functional, characterization, and molecular analytical methods, including method qualification and transfer.
- Making detailed observations, analyzing data, interpreting results, and exercising appropriate technical discretion in the design, execution, and interpretation of experiments independently.
- Carrying out analytical development/sample testing to enable lentiviral vector upstream and downstream process development.
- Authoring/reviewing technical reports, protocols, and technical summaries for presentation.
- Presenting and discussing experimental results at group/project team meetings.
The ideal candidate will have a Bachelor’s degree in Immunology, Cell Biology, Biological Sciences, Biotechnology, or related field with 5+ years of relevant experience or a Master's degree in Immunology, Cell Biology, Biological Sciences, Biotechnology, or related field with 3+ years of relevant experience.
Biotechnology or pharmaceutical industry experience working with analytical for lentiviral vector and CAR T cells is required. Experience method qualification/validation and tech transfer of cell and gene therapy analytical methods is also required.
Highly proficient in immunology techniques, such as ELISA or similar technology platforms, and molecular biology techniques, such as qPCR, dPCR, for gene edit evaluation, on target/off target analysis, is required.
Excellent written and oral communication skills, good time management and organizational skills, and the ability to prioritize tasks from multiple projects to meet timelines are essential.
Desirable skills include experience in biophysical analysis, such as DLS, HPLC, mass spectrometry, and capillary electrophoresis, Flow virometry for lentiviral vector characterization, and experience with NGS.