Principal Scientist / Senior Principal Scientist, Protein Potency & Bioassay

Lead a team of scientists to support a broad range of biologic projects, from IND to BLA, ensuring high-quality project execution and on-time delivery. Drive assay strategy development to support product characterization, release testing, stability studies, comparability assessments, and regulatory submissions. Oversee all aspects of function characterization work of protein therapeutics, including but not limited to a strong understanding of biomolecule “MoAs” such as cell/protien based binding assays, anti-proliferation assays, ADCC&CDC, cellular signal transduction/apoptosis/killing assays, etc. Lead technical investigations, method troubleshooting, and root-cause analysis for critical project challenges Establish platform capabilities, SOPs, and best practices to drive scientific excellence and operational efficiency. Mentor and develop scientific talent, fostering a culture of innovation, accountability, and continuous improvement.

Ph.D. in Biology, Immunology, Cell Biology, Pharmaceutical Sciences, or a related field Minimum 3 years of industry experience, including significant experience in potency assay development and characterization. Excellent analytical mindset and skills including hands on experience with bioassays/immunoassays; such as Binding Activity, Bioassays, Effector-function, and cell-based assay. Scientific understanding of bioassay/immunoassay technologies and applications Familiarity with regulatory filings such as IND, IMPD, and BLA Familiarity with relevant regulatory guidance documents (ICH, USP, CFR, general guidance) Strong problem-solving and troubleshooting skills, capabilities in experimental design and execution, ability to work on multiple projects simultaneously, as well ability to work independently and collaborate cross-functionally