QC Chemistry Analyst - Biotech (GMP, Large Molecule)

Denali Therapeutics; Salt Lake City (UT); Sur place; USD 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

401k

Healthcare

ESPP

Résumé du poste

Denali Therapeutics Inc. is seeking a Quality Control Analyst in Salt Lake City to execute analytical tests for in-process, drug substance, and drug product in a GMP-regulated lab.

The candidate will run chromatography-based assays and participate in method validation/transfer, stability testing, and data reporting under supervision. The role requires a BS in a related science with 4+ years of GMP-lab experience, hands-on HPLC/UPLC, and familiarity with LIMS and QA documentation.

Qualifications

• Typically requires a BS in Chemistry, Biology, Biochemistry, or a related scientific discipline.
• 4+ years of experience in a GMP-regulated laboratory.
• Hands-on chromatography (HPLC/UPLC) experience; large molecule/biologics experience preferred.

Responsabilités

• Executes routine analytical testing of raw materials, drug substance, and drug product.
• Performs chromatography-based assays (SEC, RP-HPLC, icIEF, CE-SDS, glycan analyses).
• Supports method validation/transfer and QC documentation reviews.
• Performs stability testing and data generation/reporting with data integrity.
• Maintains LabWare LIMS usage and assists with investigations and CAPA.
• Prepares reagents and ensures calibration/maintenance of instruments.

Connaissances

GMP-regulated lab

HPLC/UPLC

Data integrity

Communication

Formation

BS in Chemistry/Biology/Biochemistry

Outils

LabWare LIMS

MasterControl

Waters

Description du poste

Denali Therapeutics Inc. is seeking a Quality Control Analyst in Salt Lake City to execute analytical tests for in-process, drug substance, and drug product in a GMP-regulated lab.

The candidate will run chromatography-based assays and participate in method validation/transfer, stability testing, and data reporting under supervision. The role requires a BS in a related science with 4+ years of GMP-lab experience, hands-on HPLC/UPLC, and familiarity with LIMS and QA documentation.