Scientist, Analytical Development & Quality Control

Aspect Biosystems•Fremont, CA

11h•Onsite

About The Position

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, 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.

Requirements

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.
Proven hands-on experience with a range of analytical techniques, such as flow cytometry, ELISA, and/or cell-based assays.
Familiarity with GxP principles (GLP, GMP) and an understanding of regulatory expectations for analytical method development, qualification, and validation for biologics or advanced therapies.
You have a keen eye for detail and a methodical approach to troubleshooting analytical challenges.
You're eager to learn new techniques and contribute to the continuous improvement of analytical processes.

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.
Other duties as required.