Senior QC Scientist: Flow Cytometry & Cell-Based Assays

Allogene Therapeutics

Newark (CA)

On-site

USD 145,000 - 160,000

Full time

35 hours ago

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Benefits offered by this job

Annual bonus

Equity

Health insurance

Generous time off

Job summary

Allogene Therapeutics in Newark, CA seeks a Senior Quality Control Specialist to provide SME-level expertise in cell-based assays, flow cytometry and supportive QC methods. You will review test records, lead method development and validation, and drive CAPA investigations to maintain GMP compliance.

The role is onsite at the Newark manufacturing facility, with a focus on maintaining Turn-Around Time and robust data interpretation.

Qualifications

BS degree in a scientific discipline with minimum GMP experience.
Advanced degree preferred (PhD with 2–4 years, MS with 6 years).
Broad knowledge of cell-based assays, flow cytometry, ELISA, qPCR and ddPCR.
Experience in analytical method development/validation/transfer and reagent qualification.

Responsibilities

Serve as SME for QC test methods including flow cytometry, cell-based assays, ELISA, qPCR and ddPCR.
Review and approve QC test records and data; evaluate trends.
Lead method development, validation and transfer activities; design/execute validation protocols.
Support deviation investigations and CAPA initiation/completion.
Troubleshoot/optimize analytical methods; improve efficiency.
Assist with scheduling, training, and ensuring SOP/compliance in the QC lab.
Perform QC testing to support release and stability of products.
Represent QC in audits and interact with CTLs as needed.