Scientist Quality Control Analytical Development Aspect Biosystems
Overview
Scientist leading end-to-end development of cell-based analytical methods for bioprinted tissue therapeutics in Fremont California. This role focuses on establishing robust analytical methods while partnering with QC Process Development and Research to achieve clinical readiness. The position requires expertise in precision scalable assays and regulatory compliance.
What You'll Do11
- 1Lead development and optimization of complex bioanalytical methods including ddPCR qPCR and flow cytometry
- 2Execute thorough cell-based assays and ELISAs meeting precision scalability and regulatory standards
- 3Design experiments for product characterization raw material analysis and early-stage stability studies
- 4Perform routine analytical testing to support process development and product characterization
- 5Record analyze interpret and present experimental data accurately
- 6Author technical reports SOPs and study protocols following GxP principles
- 7Identify troubleshoot analytical method issues propose solutions and implement corrective actions
- 8Act as subject matter expert advising cross-functional teams on assay design controls and data interpretation
- 9Maintain calibrate analytical instruments ensure proper functionality
- 10Contribute to robust analytical quality systems ensuring data integrity traceability and compliance
- 11Support product development milestones and resolve analytical challenges through collaboration
Requirements8
- 1Bachelor's or Master's degree in relevant scientific discipline with 3+ years analytical development experience in biotech/pharma
- 2Hands-on experience with cell therapy gene therapy or combination products
- 3Proven proficiency with flow cytometry ELISA and cell-based assays
- 4Familiarity with GxP principles GLP GMP and regulatory expectations for biologics
- 5Demonstrated problem-solving skills with methodological challenges
- 6Innovation mindset eager to learn new techniques
- 73-5 years experience in relevant roles
- 85+ years building ETL pipelines with Spark and Airflow
Salary Insight
$86 - $102k per year
Location
Required Skills
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