Scientist, Quality Control & Analytical Development

<p>We are looking for an enthusiastic Scientist to join our Quality Control & Analytical Development team in Fremont, California. In this role, you will be a subject matter expert in and cell-based analytical methods, supporting the development, optimization, and qualification of assays used to characterize our bioprinted tissue therapeutics. Reporting to our Head of Quality Control and Analytical Development, you'll play a critical role in establishing robust analytical methods while partnering closely with QC, Process Development, and Research as programs advance toward clinical readiness.</p> <p><strong>Responsibilities </strong></p> <ul> <li>Leading the end-to-end development and optimization of complex bioanalytical methods, such as ddPCR, qPCR, and flow cytometry. </li> <li>Thorough execution of cell-based assays and ELISAs, ensuring all analytical platforms meet the highest standards of precision, scalability, and regulatory compliance.</li> <li>Designing and executing analytical experiments to support product characterization, comparability, and process understanding for raw materials, in-process samples, and drug products.</li> <li>Participating in and executing experiments for the qualification and validation of analytical methods, contributing experimental data, protocols, and technical expertise.</li> <li>Performing routine analytical testing as needed to support process development, product characterization, and early-stage stability studies.</li> <li>Accurately record, analyze, interpret, and present experimental data. Author and review technical reports, study protocols, and standard operating procedures (SOPs) in compliance with GxP principles.</li> <li>Identifying and troubleshoot analytical method issues, propose solutions, and implement corrective actions.</li> <li>Acting as a subject matter expert, advising cross-functional teams on assay design, controls, and data interpretation.</li> <li>Working cross functionally with Process Development, Quality Control, Research & Development, and Manufacturing to support product development milestones and resolve analytical challenges.</li> <li>Performing routine maintenance and calibration of analytical instruments and ensuring proper functioning.</li> <li>Adhering to and contributing to the development of robust analytical quality systems, ensuring data integrity, traceability, and compliance with internal and external regulations.</li> </ul> <p><strong>Qualifications & Experience</strong></p> <ul> <li><strong>Education & Experience:</strong> Bachelor's or Master's degree in a relevant scientific discipline with 3+ years of relevant experience in analytical development within the biotechnology or pharmaceutical industry with hands-on experience in cell therapy, gene therapy, or combination products. </li> <li><strong>Analytical Expertise:</strong> Proven hands-on experience with a range of analytical techniques, such as flow cytometry, ELISA, and/or cell-based assays.</li> <li><strong>GxP Knowledge:</strong> Familiarity with GxP principles (GLP, GMP) and an understanding of regulatory expectations for analytical method development, qualification, and validation for biologics or advanced therapies.</li> <li><strong>Problem-Solver:</strong> You have a keen eye for detail and a methodical approach to troubleshooting analytical challenges.</li> <li><strong>Innovation Mindset:</strong> You're eager to learn new techniques and contribute to the continuous improvement of analytical processes.</li> </ul> <p>The hiring range for this role is $86,000 - $102,000, annually. Our ranges are based on market data. O