Principal Scientist, CMC Pipeline Innovation

About the position Responsibilities • Identify and address analytical gaps across pipeline programs by implementing innovative and strategic solutions. • Scout, evaluate, create, and implement emerging analytical technologies aimed at improving sensitivity, specificity, throughput, turnaround time, and robustness of methods. • Provide technical assessments and recommendations for new analytical platforms, including feasibility, risk, and implementation timelines. • Design and execute lab-based proof-of-concept studies to demonstrate the value of novel analytical tools in characterizing complex biologics and cell therapies. • Define roadmaps for integrating new analytical technologies across the entire portfolio lifecycle, from early development through commercialization. • Collaborate with external partners and technology providers to evaluate new platforms and contribute to partnership strategies. • Monitor industry trends, scientific literature, and regulatory guidance to stay at the forefront of analytical innovation. • Collaborate across functions to ensure seamless integration of new analytical capabilities into development and quality systems. • Contribute to regulatory submissions by providing technical documentation and justification for novel analytical approaches. • Apply knowledge of analytical comparability to support product transitions across development stages. • Cell culture, clonal isolation and banking. • Empowered to define and guide technical direction, including the development of methodologies and detailed scientific or engineering approaches. Requirements • B.S., M.S., or Ph.D. in Analytical Chemistry, Biochemistry, Biology, Biomedical Engineering, or a related field with 8+ years of applied technical experience. • Deep expertise in analytical method development and validation for complex cell/gene therapies. • Familiarity with lentiviral vector (LVV) characterization assay development is highly desirable. • Hands-on experience with advanced analytical platforms such as NGS, flow cytometry, nano flowcytometry and Capillary Gel Electrophoresis w/ Laser-Induced Fluorescence (CGE-LIF), ELLA, JESS, DLS, Leprechaun and advance Transcriptomic techniques (microarray, scRNA-Seq, etc.). • In vitro PBMC based transduction assay and Potency assay development experience. • Experience with automation, data integration, and digital tools to enhance analytical workflows is a plus. • Familiarity with Machine Learning & Artificial intelligence a plus. • Strong understanding of regulatory expectations for analytical methods in clinical and commercial settings. • Excellent communication and collaboration skills to work across technical functions. • IT Skills: Microsoft Office (Access, Excel, PowerPoint, Visio, Word, Project), JMP, GraphPad Prism, Smartsheet, R, SoftMax Pro, LIMS, FlowJo or equivalent. • English required; Mandarin is a plus. Benefits • Medical, dental, and vision insurance. • 401(k)-retirement plan with company match that vest fully on day one. • Equity and stock options available to employees in eligible roles. • Eight weeks of paid parental leave after just three months of employment. • Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. • Flexible spending and health savings accounts. • Life and AD&D insurance. • Short- and long-term disability coverage. • Legal assistance. • Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. • Commuter benefits. • Family planning and care resources. • Well-being initiatives. • Peer-to-peer recognition programs. Apply tot his job Apply To this Job