Scientist, Quality Control & Analytical Development

Scientist, Quality Control & Analytical Development

Fremont

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.
• GxP Knowledge: Familiarity with GxP principles (GLP, GMP) and an understanding of regulatory expectations for analytical method development, qualification, and validation for biologics or advanced therapies.
• Problem-Solver: You have a keen eye for detail and a methodical approach to troubleshooting analytical challenges.
• Innovation Mindset: You're eager to learn new techniques and contribute to the continuous improvement of analytical processes.

The hiring range for this role is $86,000 - $102,000, annually. Our ranges are based on market data. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Note that base salary is just one part of the overall compensation bers of the Aspect team also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.