Senior Specialist, QC (Biotech)

TL;DR

Senior Specialist, QC (Biotech): Providing scientific technical expertise to the QC analytical laboratory with an accent on cell-based methods, method lifecycle management, and GMP compliance. Focus on designing and validating analytical methods, troubleshooting instruments, and ensuring product release stability.

Location: Newark, CA. Must be authorized to work in the U.S.

Salary: $130,000 – $155,000 per year

Company

A clinical-stage biotechnology company pioneering hirify.globalic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Serve as SME for flow cytometry, cell-based assays, ELISA, qPCR, and ddPCR, designing and developing methods as needed.
• Lead method validation and transfer activities, authoring validation protocols and reports.
• Define and execute critical reagent qualification and reference standards programs.
• Perform routine QC analytical testing to support the release and stability of final products.
• Conduct technical investigations for discrepancies, Out Of Specification (OOS) results, and initiate CAPAs.
• Support GMP audits and inspection-related needs.

Requirements

• Bachelor’s degree in a scientific discipline with 8+ years of experience in a GMP environment.
• Broad expertise in Flow cytometry, ELISA, qPCR, and ddPCR.
• Experience in analytical method development, validation, transfer, and reagent qualification.
• Proficiency in Microsoft Office Suite and Statistical software (JMP).
• Strong communication skills for effective cross-functional collaboration.
• Must be authorized to work in the U.S.

Culture & Benefits

• Annual performance bonus and equity options.
• Comprehensive health insurance package.
• Generous time off, including two annual company-wide holiday shutdowns.
• Collaborative work environment with a focus on life-changing products for patients.