Principal Scientist – Bioanalytical and Molecular Assay
| Company | Moderna |
|---|---|
| Location | Norwood, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Expert or higher |
Requirements
- Ph.D. in Cell Biology, Immuno-oncology, Immunology, Cancer Biology, or related fields with a minimum of 9+ years of biotech/pharmaceutical industry experience
- A B.S./M.S. with extensive bioanalytical experience will also be considered
- Expert knowledge of cell-based assays, including flow cytometry and ELISpot or similar methodologies for pre-clinical and clinical assays
- Strong understanding of GLP requirements and current industry trends and regulatory expectations associated with bioanalytical science
- Deep knowledge of regulatory guidances such as BMV, M10 and similar
Responsibilities
- Design and execute phase-appropriate clinical bioanalytical strategies, including quantitation and characterization of engineered cell therapies and immunogenicity evaluations (ADA, APA, nAb, ELISpot) of mRNA-LNP therapeutics
- Lead a team to ensure timely assay development, regulatory-compliant qualification or validation of assays, and troubleshooting of any internal or external CRO partner issues
- Develop cell-based nAb assays, cell therapy PD assays (Flow Cytometry), immune cell activation assays (ELISpot), APA, and/or PD assays using technologies such as ELISA, MSD, Gyros, multiplex LBAs, and Luminex-based protein assays
- Support and facilitate method development to support Moderna’s portfolio, including analytical equipment procurement/qualifications and preparation and maintenance of SOPs
Preferred Qualifications
- Preferred experience with RNA, biologics, and cell therapy
- Ability to effectively communicate scientific concepts, program objectives, and data analysis within a matrix environment
- Hands on knowledge of various Laboratory Information Management Systems such as Thermo Watson, LabVantage, ELN etc. Knowledge of AI application in regulated bioanalysis is preferred