Scientist I, QC Analytical
Core
Execute analytical testing, method validation, and troubleshooting for gene therapy products (AAV vectors, plasmids, cell banks) in a cGMP environment.
Role type
Scientist I, QC Analytical (Subject Matter Expert)
Builds
In-process, release, and stability testing data for gene therapy products
Domain
Biotechnology / Gene Therapy / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, analytical method execution, troubleshooting, data interpretation, root cause analysis, regulatory documentation, mentoring junior staff, EQMS/LIMS proficiency
Preferred skills
Advanced degree (Master's/PhD), SME in nucleic acid/protein/cell-based assays, experience with ddPCR/qPCR/CE/AUC/TCID50
Technologies
ddPCR, qPCR, CE, AUC, TCID50, ELISA, LIMS, EQMS
Responsibilities
Perform in-process, release, and stability testing for viral vector/gene therapy products; Function as SME for nucleic acid, protein, or cell-based assays; Support troubleshooting of processes/assays; Conduct OOS investigations and implement CAPAs; Author and review QC documentation (SOPs, protocols); Provide technical guidance and mentorship to junior team members; Manage tracking and trending of testing data.
Seniority
Individual Contributor, entry-to-mid level with SME expectations
