QC Automation Specialist - Liquid Handling

Key Responsibilities

• Develop, qualify, and optimize automated methods for cell therapy QC assays, including flow cytometry, cell-based assays, molecular-based assays, cell viability testing, and related biologics assays
• Program, troubleshoot, and improve automation scripts for liquid handlers such as Hamilton, Tecan, or similar platforms
• Support integrated automation workflows and lab orchestration systems, including platforms such as Cellario, HighRes BioSolutions, or similar systems
• Translate manual assay methods into automated workflows and demonstrate comparability, robustness, and fitness for intended use through defined development studies
• Troubleshoot automated workflows, scripts, instruments, hardware/software issues, and assay execution challenges
• Author development reports, work instructions, technical documentation, and supporting records in compliance with GMP requirements
• Support method qualification, technical transfer, validation-related activities, and audit/inspection readiness as needed
• Drive continuous improvement initiatives for automated QC systems, assay workflows, and operational efficiency
• Support training sessions and create documentation to enable successful hand-off of automated methods and workflows

Requirements

• Bachelor's degree in Life Sciences, Engineering, Biotechnology, Biology, Bioengineering, Chemistry, Biochemistry, or a related field with 5+ years of experience in analytical, bioanalytical, or automation assay development
• Master's degree with 3-5 years of experience, or Ph.D. with 1-3 years of experience in analytical, bioanalytical, or automation assay development may also be considered
• 3-5 years of hands-on experience automating biologics and/or cell therapy assays
• Demonstrated hands-on experience developing, programming, and troubleshooting automation scripts for liquid handlers such as Hamilton, Tecan, or similar platforms
• Experience with automated QC, analytical, bioanalytical, biologics, or cell therapy assay workflows
• Experience with integrated automation systems and/or lab orchestration tools such as Cellario, HighRes BioSolutions, or similar platforms
• Strong troubleshooting skills with the ability to resolve automated workflow, hardware, software, and assay execution issues
• Familiarity with GMP, QC regulatory expectations, technical documentation, and validation support in a biopharmaceutical environment
• Strong written and verbal communication skills with the ability to work collaboratively across multidisciplinary teams
• Flexibility and eagerness to learn new technologies, platforms, and techniques

Preferred Qualifications

• Experience with programming languages such as Python, Visual Basic, or similar tools used in automation workflows
• Background in aseptic technique and bioprocess sample handling
• Experience in analytical method development for cell therapy, biologics, or related therapeutic platforms
• Experience supporting audits, inspections, validation activities, and GMP documentation
• Hands-on experience with flow cytometry, cell-based assays, molecular assays, or cell viability assays