Senior Analytical Development Scientist – GMP Biologics

Kelly; Los Angeles (CA); On-site; USD 120,000 - 135,000; Full time

Job summary

Kelly is seeking an Analytical Development Scientist for an on-site role in the Los Angeles area. The position focuses on developing cell-based, ELISA, HPLC, and CE methods to characterize protein biologics and support validation, process development, and stability studies in GMP and non-GMP environments.

The role interfaces with PM, QC, MFG, and external clients, leading testing and data analysis, authoring SOPs, and contributing to continuous improvement initiatives.

Qualifications

• BS degree in Biochemistry, Chemistry, Biology, or a related field.
• 8+ years of biotech industry experience working in a QC or analytical lab.
• Experience with analytical testing, GMPs, and regulatory audits.
• HPLC, CE, or Potency/ELISA experience is essential.
• Protein characterization, electrophoresis, chromatography, and assay validation.

Responsibilities

• Develop, perform, troubleshoot, and review routine wet chemistry/ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/CE) and/or HPLC.
• Research, analyze, and report data with scientific justification and under supervision.
• Train/supervise junior analysts and prepare technical reports for senior personnel.
• Manage client projects and collaborate with MFG, QC, PM; provide scientific insights for decisions.
• Develop, review, revise, and write test methods, forms, SOPs, and related documents.
• Act as SME for QC and support regulatory inspections.

Skills

HPLC

ELISA

Cell-based assays

SDS-PAGE

Education

BS in Biochemistry/ Chemistry/ Biology

Tools

GMP knowledge

Job description

Kelly is seeking an Analytical Development Scientist for an on-site role in the Los Angeles area. The position focuses on developing cell-based, ELISA, HPLC, and CE methods to characterize protein biologics and support validation, process development, and stability studies in GMP and non-GMP environments.

The role interfaces with PM, QC, MFG, and external clients, leading testing and data analysis, authoring SOPs, and contributing to continuous improvement initiatives.