Scientist, Quality Control & Analytical Development

Job description

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 at Aspect. Members of the Aspect team also receive equity, a comprehensive benefits package, and support for continuous learning and career progression. **Who We Are** Aspect Biosystems is a biotechnology company pioneering the development of a novel category of regenerative medicine designed to restore or supplement biological function and deliver curative therapies for some of the most elusive diseases. Aspect is developing these bioengineered cellular medicines by applying its full-stack tissue therapeutic platform, which integrates proprietary AI-powered bioprinting technology, therapeutic cells, hypoimmune cell engineering, and advanced biomaterials. Aspect is advancing its therapeutic pipeline across multiple endocrine and metabolic diseases, including diabetes and rare endocrine disorders. If you are committed to making a real impact and accelerating the development of life-changing therapies, we want to hear from you! Curious about our current perks and benefits? Learn more [here](https://aspectbiosystems.com/careers). At Aspect Biosystems, our strength has always been in our diversity. Different people, thinking differently, unified in creating a world that is better for us all. We are committed to creating an inclusive environment for everyone on our team. All aspects of employment — including the decision to hire, promote, discipline, or terminate — are based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, citizenship status, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, political affiliation, or any other status protected under federal, state, provincial, or local law. If you're interested in joining our team but don't see a job posting that matches your experience or background, we encourage you to [submit a general application](https://boards.greenhouse.io/aspectbiosystems/jobs/4009049008) to be considered for future opportunities!