Scientist

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.

Responsibilities 

• Leading the end-to-end development and optimization of complex bioanalytical methods, such as ddPCR, qPCR, and flow cytometry. 
• Thorough execution of cell-based assays and ELISAs, ensuring all analytical platforms meet the highest standards of precision, scalability, and regulatory compliance.
• Designing and executing analytical experiments to support product characterization, comparability, and process understanding for raw materials, in-process samples, and drug products.
• Participating in and executing experiments for the qualification and validation of analytical methods, contributing experimental data, protocols, and technical expertise.
• Performing routine analytical testing as needed to support process development, product characterization, and early-stage stability studies.
• 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.
• Identifying and troubleshoot analytical method issues, propose solutions, and implement corrective actions.
• Acting as a subject matter expert, advising cross-functional teams on assay design, controls, and data interpretation.
• Working cross functionally with Process Development, Quality Control, Research & Development, and Manufacturing to support product development milestones and resolve analytical challenges.
• Performing routine maintenance and calibration of analytical instruments and ensuring proper functioning.
• Adhering to and contributing to the development of robust analytical quality systems, ensuring data integrity, traceability, and compliance with internal and external regulations.

Qualifications & Experience

• Education & Experience: 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. 
• Analytical Expertise: Proven hands-on experience with a range of analytical techniques, such as flow cytometry, ELISA, and/or cell-based assays.