Scientist, QC & Analytical Development - Cell Therapy

Aspect-Biosystems; Fremont (CA); On-site; USD 86,000 - 102,000; Full time

Job summary

Aspect Biosystems in Fremont, California seeks a Scientist to join the Quality Control & Analytical Development team to advance cell-based analytical methods for bioprinted tissue therapeutics.

You will lead end-to-end development of ddPCR, qPCR, and flow cytometry assays; perform ELISAs; ensure GxP compliance; and collaborate with Process Development, QC, Research & Development, and Manufacturing to support product characterization and clinical readiness.

Qualifications

• Education & experience: Bachelor's or Master's in a relevant science with 3+ years in analytical development in biotech/pharma, cell therapy, gene therapy, or related fields.
• Analytical expertise: hands-on with flow cytometry, ELISA, and/or cell-based assays.
• GxP knowledge: familiarity with GLP/GMP and regulatory expectations for analytical method development, qualification, and validation.
• Problem solver: detail-oriented with a methodical troubleshooting approach.
• Innovation mindset: eager to learn new techniques and improve analytical processes.

Responsibilities

• Lead the end-to-end development and optimization of complex bioanalytical methods, such as ddPCR, qPCR, and flow cytometry.
• Execute cell-based assays and ELISAs ensuring precision, scalability, and regulatory compliance.
• Design and run analytical experiments for product characterization, comparability, and process understanding.
• Participate in qualification and validation of analytical methods and contribute data, protocols, and technical expertise.
• Perform routine analytical testing to support process development and early-stage stability studies.
• Record, analyze, interpret, and present data; author SOPs and technical reports in line with GxP.
• Identify and troubleshoot method issues; propose solutions and implement corrective actions.
• Advise cross-functional teams on assay design, controls, and data interpretation.
• Collaborate with Process Development, QC, R&D, and Manufacturing to meet development milestones.
• Maintain and calibrate analytical instruments and ensure proper functioning.
• Contribute to analytical quality systems to ensure data integrity and regulatory compliance.

Skills

Analytical development

Cell-based assay expertise

Flow cytometry

ELISA

qPCR

ddPCR

GxP knowledge

Problem solving

Education

Bachelor's or Master's degree in a relevant scientific discipline

Tools

ddPCR

qPCR

Flow cytometry

Job description

Aspect Biosystems in Fremont, California seeks a Scientist to join the Quality Control & Analytical Development team to advance cell-based analytical methods for bioprinted tissue therapeutics.

You will lead end-to-end development of ddPCR, qPCR, and flow cytometry assays; perform ELISAs; ensure GxP compliance; and collaborate with Process Development, QC, Research & Development, and Manufacturing to support product characterization and clinical readiness.