Stage 4 Solutions · 1 day ago
QC Automation Scientist – Cell Therapy (Onsite – Seattle, WA)
Stage 4 Solutions is seeking a QC Automation Scientist – Cell Therapy for a global pharmaceutical client. The role focuses on supporting the development, qualification, and implementation of automated QC methods for cell therapy assays, requiring collaboration with various teams to enhance automated QC systems.
ConsultingAdvertisingMarketingManagement Consulting
Responsibilities
Develop, and qualify automated methods for Cell therapy QC assays (e.g., flow cytometry, cell-based assays, molecular-based assays, and cell viability) using automated liquid handlers and integrated platforms
Program and troubleshoot scripts for liquid handlers (e.g., Hamilton) and lab orchestration software (e.g. Cellario)
Demonstrate that automated assay scripts developed from manual methods are comparable, robust, and fit for intended use through execution of defined development studies
Author development reports, work instructions, and supporting technical documentation in compliance with GMP requirements, and support associated validation activities as required
Drive troubleshooting and continuous improvement initiatives for automated workflows and systems
Drive training sessions and supporting documentation to support hand-off
Qualification
Required
5+ years in analytical, bioanalytical, or automation assay development
3-5 years of hands-on experience in automation of biologic and Cell Therapy assays
Demonstrated proficiency in developing and programming automation scripts for liquid handlers (Hamilton, Tecan, or similar platforms)
Experience with integrated automation systems and lab orchestration tools (e.g., Cellario, HighRes BioSolutions)
Strong problem-solving skills and ability to troubleshoot automated workflows and hardware/software issues
Familiarity with regulatory requirements for QC in the biopharmaceutical industry and experience supporting audits and inspections
Bachelor's in Life Sciences, Engineering, or related field OR Master's OR PHD in the same area
Preferred
Experience with programming languages (Python, Visual Basic, etc.) for automation workflows
Background in aseptic technique and bioprocess sample handling
Experience in analytical method development for cell therapy or biologics
Benefits
Health benefits
401K
Company
Stage 4 Solutions
Stage 4 Solutions is a management consulting firm that provides marketing solutions services.
Funding
Current Stage
Growth StageRecent News
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