The Scientist/Senior Scientist will join a highly motivated team of scientists and associates developing novel genetic therapies for respiratory diseases and will be responsible for development and execution of bioanalytical assays to support pre-clinical studies.
- Develop and execute robust bioanalytical assays to support cell-based and in vivo studies. These assays will focus initially on detection and quantitation of target protein expression and mRNA cargo as well as immunogenicity and tolerability of the drug candidates.
- Work closely with cell culture, in vivo, RNA production, and formulation teams to coordinate sample processing and bioanalytical assays.
- Work with research associates on experimental design, troubleshooting, assay optimization and data interpretation as needed.
- Represent Bioanalytical Development in cross functional study teams to maintain effective communication and provide project status and progress reports. Review (QC) data and writing SOPs and technical reports.
- PhD with 3+ years of industry experience preferably in a development (Bioanalytical, QC) environment. Must be familiar with bioanalytical GxP guidance.
- Hands-on experience with design, development, optimization, qualification, and validation of novel bioassays and immunoassays using multiple platforms and technologies (e.g. ELISA, MSD/Luminex, flow cytometry, cytokine analyses, and cell-based reporter and cytotoxicity assays).
- Strong foundation in molecular biology and gene expression analysis methods (e.g. Quantitative RT-PCR, ddPCR).
- Experience with protein analytical methods (SDS-PAGE, Western Blotting).
- Experience with sample processing methods to support protein and nucleic acid detection from a variety of tissue types.
- Track record of developing technical assays/methods and SOPs.
- Experience working in a GxP environment, and CRO management for method transfer is a plus.
- Excellent skills in Microsoft Office, data analysis software (e.g. Prism, JMP, FlowJo, FACSDiva, SoftMax Pro), and other applications.
- Must be comfortable in a fast-paced small company environment with minimal direction.
- Self-starter with excellent interpersonal skills and demonstrated success working with multi-disciplinary teams in a matrix environment.
- Strong oral and written communication skills to support internal and external communications/presentations.