Biologics QC Analyst – Precision GMP Testing

Denali Therapeutics Inc; Salt Lake City (UT); Presencial; USD 80.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k

Healthcare coverage

ESPP

Broad range of benefits

Descripción de la vacante

Denali Therapeutics Inc. in Salt Lake City seeks a QC/Analytical Chemistry specialist to perform routine and ad hoc testing of raw materials, drug substance, and drug product using chromatographic methods.

The role supports method validation, transfer, stability testing, and data reporting within GMP framework. The ideal candidate holds a BS in Chemistry or related field with 4+ years in a GMP lab, hands-on HPLC/UPLC experience, and familiarity with LIMS (LabWare).

Formación

• BS in Chemistry or related field with GMP laboratory experience.
• 4+ years in a GMP-regulated lab with hands-on chromatography experience.
• Experience with LIMS and quality management systems.

Responsabilidades

• Execute routine and ad hoc analytical testing of materials and products per approved methods.
• Perform chromatography-based analyses including HPLC/UPLC, icIEF, CE-SDS, and related assays.
• Support method validation, transfer, and implementation activities under supervision.
• Generate, process, and report analytical data with data integrity. Escalate anomalies.
• Maintain instrument readiness, calibrations, and supplies; support QA investigations.

Conocimientos

GMP experience

HPLC/UPLC

Written & verbal communication

Independent work

LIMS experience

Educación

BS in Chemistry or related

Herramientas

LabWare LIMS

MasterControl

Waters Empower

Descripción del empleo

Denali Therapeutics Inc. in Salt Lake City seeks a QC/Analytical Chemistry specialist to perform routine and ad hoc testing of raw materials, drug substance, and drug product using chromatographic methods.

The role supports method validation, transfer, stability testing, and data reporting within GMP framework. The ideal candidate holds a BS in Chemistry or related field with 4+ years in a GMP lab, hands-on HPLC/UPLC experience, and familiarity with LIMS (LabWare).