Principal Scientist in Cell, Molecular, and Immunology

Role Summary

Principal Scientist, Cell, Molecular, and Immunology supporting vaccine development in the Analytical Research and Development team. Drive scientific development and execute assays to evaluate early-stage vaccine candidates, from discovery through GLP‑Tox batch characterization. Bring extensive knowledge of analytical development in ligand-binding assays, cell-based assays, and molecular biology assays to characterize quality attributes for drug substance, drug product, process intermediates, and preclinical candidates. A strong understanding of the vaccine development lifecycle and relevant regulatory guidance is required.

Responsibilities

• Serve as a key contributor across a diverse team of scientists within a global organization; act as a strong technical leader in the laboratory, and be an excellent communicator and collaborator with peers and across functions.
• Plan and execute ligand-binding assays, including ELISA, Luminex, Quanterix, Western blotting, Gyros, and AlphaLISA.
• Develop and execute cell-based assays, including expression analysis by flow cytometry, high-content imaging, Western blotting, or other related technologies.
• Analyze and interpret experimental data, and document results in electronic laboratory notebooks in a detailed and concise manner.
• Write detailed protocols, procedures, and work instructions to support assays.
• Draft technical sections of internal and external reports, and contribute to scientific papers and patents.
• Author technical reports for regulatory filings.
• Report results in team, cross-functional, and cross-department meetings.
• Maintain strong organization to track key project-related deadlines.
• Multi-task effectively and contribute to multiple projects concurrently.
• Contribute to the maintenance of a clean and safe workplace.

Qualifications

• Required: Degree in Immunology, Molecular Biology, Biochemistry, Bioengineering, Pharmaceutical Sciences, or a related scientific field.
• Required: PhD with ≥4 years of postdoctoral or industry experience, MS with ≥8 years of industry experience, or BS with ≥10 years of laboratory experience.
• Required: ≥3 years of experience with ELISA, Luminex, flow cytometry, ligand-binding assays, Western blotting, and/or cell-based assays.

Preferred Qualifications

• ≥3 years of analytical method development supporting vaccines.
• Strong track record of scientific publications in peer-reviewed journals, or other demonstrations of scientific success.
• Prior experience implementing robotic systems to increase analytical efficiency.
• ≥3 years of experience developing analytical templates in SoftMax Pro, Prism, or other analytical software.
• Knowledge of statistical analysis.
• Experience writing technical documents to support the analytical lifecycle (technical memos, feasibility, qualification, method transfer), or authoring CMC sections for regulatory filings.
• Experience in mammalian cell culture.
• Familiarity with ICH Q2(R1).