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Salary: USD 86,000 - 102,000 / annual
Aspect Biosystems is seeking a Scientist to join the Quality Control & Analytical Development team in Fremont, California. This role focuses on developing, optimizing, and qualifying analytical methods to characterize bioprinted tissue therapeutics as they advance toward clinical readiness.
Key responsibilities include leading end-to-end development of complex bioanalytical methods such as ddPCR, qPCR, and flow cytometry. You will execute cell-based assays and ELISAs to ensure analytical platforms meet precision, scalability, and regulatory compliance standards. The role involves designing and executing analytical experiments to support product characterization, comparability, and process understanding across raw materials, in-process samples, and drug products.
You will participate in qualification and validation of analytical methods, contributing experimental data, protocols, and technical expertise. Routine analytical testing supports process development, product characterization, and early-stage stability studies. Data management is critical—you will accurately record, analyze, interpret, and present experimental findings, authoring and reviewing technical reports, study protocols, and SOPs in compliance with GxP principles.
Troubleshooting analytical method issues and proposing solutions is essential. You will serve as a subject matter expert, advising cross-functional teams on assay design, controls, and data interpretation. Collaboration with Process Development, Quality Control, R&D, and Manufacturing teams is ongoing. Additional responsibilities include routine maintenance and calibration of analytical instruments and contributing to robust analytical quality systems ensuring data integrity and regulatory compliance.
Required qualifications include a Bachelor's or Master's degree in a relevant scientific discipline with 3+ years of analytical development experience in biotechnology or pharmaceutical industries, with hands-on experience in cell therapy, gene therapy, or combination products. Proven expertise with flow cytometry, ELISA, and cell-based assays is essential. Familiarity with GxP principles (GLP, GMP) and regulatory expectations for analytical method development in biologics or advanced therapies is required. Strong problem-solving skills, attention to detail, and an innovation mindset are valued.
