Senior Scientist, QC Analytical
Core
Perform and support analytical and molecular biology assays (ELISA, qPCR, ddPCR, HPLC, capillary electrophoresis) to ensure GMP manufacturing for clinical and commercial clients.
Role type
Senior Scientist, QC Analytical
Builds
High-quality gene therapy and vaccine products
Domain
Biopharmaceuticals / Gene Therapies
Required skills
ELISA, qPCR, ddPCR, HPLC, capillary electrophoresis, DNA/RNA extraction, GMP practices, SOP writing, biochemistry, data interpretation, change control management, CAPA, deviation handling, OOS investigations
Preferred skills
Advanced troubleshooting of laboratory instrumentation, mentoring laboratory staff, leading continuous improvement initiatives
Technologies
ELISA, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Microsoft Excel, Microsoft Word
Responsibilities
Perform and support a broad range of analytical and molecular biology assays; Troubleshoot laboratory, testing, and instrumentation issues; Serve as a subject matter expert for key analytical techniques; Mentor, train, and develop laboratory staff; Lead and support continuous improvement initiatives; Create, revise, and maintain technical documentation including SOPs; Review laboratory work and approve data packages; Manage and support change controls, CAPAs, deviations, and OOS investigations; Monitor laboratory equipment performance
Seniority
Senior, hands-on IC