Scientist II, QC Analytical (2nd Shift)
Core
Lead QC staff and perform advanced analytical testing for AAV-based gene therapy products to ensure quality, potency, and safety per cGMP standards.
Role type
Senior IC Scientist II with management responsibilities (QC Lead)
Builds
AAV vector therapeutic candidates for pre-clinical, clinical, and commercial activities
Domain
Biotechnology / Gene Therapy / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, analytical assay execution (qPCR, ELISA, SDS-PAGE, Western blot, HPLC), root cause analysis, SOP authoring, team mentorship, data interpretation, electronic quality management systems (EQMS/LIMS)
Preferred skills
Subject Matter Expertise in Cell/Protein/Nucleic Acid assays, Microsoft software, Veeva, ADP
Technologies
qPCR, ELISA, SDS-PAGE, Western blot, HPLC, EQMS, LIMS
Responsibilities
Perform in-process, release, and stability testing for AAV candidates; lead and perform advanced analytical QC assays; conduct OOS investigations and implement CAPAs; mentor junior team members and manage performance appraisals; author and review QC reports, SOPs, and specifications; support regulatory inspections and internal audits.
Seniority
Senior, hands-on IC with management duties
