Senior Bioassay Scientist, Cell-Based Potency (Biologics)

Exelixis, Inc.; Alameda (CA); Vor Ort; USD 128.000 - 181.000; Vollzeit

Benefits dieser Stelle

401k plan

Health insurance

Stock options

Discretionary bonus

Paid holidays

Vacation days

Zusammenfassung

Exelixis, Inc. in Alameda, CA seeks a Senior Scientist I, Analytical Development, Biologics CMC.

This hands-on role will establish and advance phase-appropriate cell-based potency and binding assays for biologics, reflecting mechanism of action and critical quality attributes. You will develop, optimize, qualify, and transfer assays; perform mammalian cell culture and engineered cell models; apply flow cytometry, ELISA, SPR/BLI; review procedures and regulatory-supporting summaries; collaborate

Qualifikationen

• Hands-on experience developing complex cell-based bioassays from concept through transfer.
• Experience with mammalian cell culture, transient transfection, and engineered cell models.
• Ability to analyze flow cytometry and binding data and write technical reports.
• Knowledge of CMC lifecycle and regulatory-supporting documentation.

Aufgaben

• Develop complex cell-based bioassays from concept through transfer.
• Perform mammalian cell culture, transfection, and engineered cell models.
• Develop and troubleshoot functional bioassays (reporter-gene, cytotoxicity, proliferation, receptor blockade, ADCC/CDC).
• Apply flow cytometry, ELISA, plate-based binding assays, SPR/BLI to support development and comparability.
• Evaluate assay performance, robustness, and transfer readiness; write development and regulatory documents.

Kenntnisse

Cell-based bioassay development

Mammalian cell culture

Flow cytometry

Binding/kinetic methods (SPR/BLI)

Phase-appropriate method development

Technical writing

Ausbildung

Ph.D. in life sciences

Master’s degree +5+ years

Bachelor’s degree +7+ years

Tools

SPR

BLI

ELISA

Jobbeschreibung

Exelixis, Inc. in Alameda, CA seeks a Senior Scientist I, Analytical Development, Biologics CMC.

This hands-on role will establish and advance phase-appropriate cell-based potency and binding assays for biologics, reflecting mechanism of action and critical quality attributes. You will develop, optimize, qualify, and transfer assays; perform mammalian cell culture and engineered cell models; apply flow cytometry, ELISA, SPR/BLI; review procedures and regulatory-supporting summaries; collaborate