Scientist/Senior Scientist - Bioanalytical Assay Development
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.
- Author SOPs and tech transfer documentation and support tech transfer to external CROs.
- PhD with 3+ years of industry experience in bioanalytical assay development.
- 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).
- Hands-on knowledge of recombinant protein expression and purification methods would be a plus.
- 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.
- Familiarity with regulatory guidance and IND filing would be 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.