Our client, an emerging biotech company developing innovative methods for solid tumor therapies through the application of gene therapy and synthetic biology, is currently seeking a Principal Scientist, Molecular Biology Assay Development to join their Analytical Development Organization. This person will be responsible for molecular assay development efforts, both internally and in collaboration with industry partners, to deliver best-in-class methods that will drive the development of the company's manufacturing technology platform for autologous and allogeneic (gene-edited) transgenic TCR T-cell therapy bioproduction.Responsibilities
- Set-up and run the molecular biology laboratory and build and lead Molecular Biology Assay team.
- Ensure development, optimization, and qualification/validation of molecular biology methods as appropriate for product characterization, process development, quality testing and release.
- Support analytical technology transfer of molecular biology assays to QC laboratories of qualified CMO's, development partners, and/or internal manufacturing sites.
- Conceptualize, design, and execute study plans to develop novel assays as part of continuous improvement for product and process characterization and understanding to support existing product platform as well as new therapeutic candidates and/or new product platforms (e.g., gene edited allogeneic TCR T cells).
- Molecular biology assays include multiple techniques (qPCR, ddPCR, RNA seq, sequencing) used in vector and cell product release assays (identity, integrity, purity) and stability and characterization testing (e.g., genomic DNA integrity, translocation, off target cleavage, etc.).
- Stay current with cutting-edge techniques in cell therapy bioanalytic to support deeper cell characterization and orient quality control strategy.
- Perform routine characterization testing as needed to support product and process development and manufacturing activities.
- Ph.D. in the life sciences (e.g., Immunology, Molecular Biology or Genetics) with a minimum of 8+ years related biopharmaceutical experience, or MS with a minimum of 12+ years of related biopharmaceutical experience, or equivalent.
- Familiarity with immunology and T cell biology is required, and assay development for CAR-T or TCR cell therapies is highly preferred.
- Demonstrated, extensive hands-on experience with various molecular biology techniques such as Gel/Capillary electrophoresis, Sanger sequencing, NGS, RNA seq, qPCR, ddPCR (incl. DNA isolation, quantitation, primer and probe design) and accompanying software proficiency and applicable bioinformatics tools.
- Molecular cloning skills (PCR-based or fragment assembly, transformation) are preferred.
- Familiarity with the analytical development of flow cytometric analysis assay and cell-based bioassays including cytotoxicity, proliferation, and potency assays is preferred.
- Understanding and experience regarding the principles of analytical test methods that must be defined during development and validation including, sensitivity, specificity, linearity, accuracy, precision, intermediate precision, and dynamic range.
- Excellent communication skills, both verbal and written, and the ability to interface effectively with process engineering, regulatory, clinical, quality, discovery research, and administration. Additionally, strong communication skills with outside vendor organizations are required.
- Drive and desire to build and sustain a high performing team of associates and scientists within a highly patient- and people-centric company culture
If you are interested in this position, please send your resume to firstname.lastname@example.org