Senior QC Lead - Biologics GMP Testing & Release

BioTalent; Tustin (CA); On-site; USD 64,000 - 79,000; Full time

Job summary

BioTalent is seeking a Lead Analyst, Quality Control to join our GMP biopharmaceutical team. You will lead analytical testing activities and coordinate assay qualification, method validation, and tech transfer projects for life-saving biologics.

This role requires a Bachelor's in Biology or Chemistry and at least six years of GMP experience, with strong cell-based assays, qPCR, ELISA, and analytical chemistry expertise.

Qualifications

• Bachelor's degree in Biology, Biochemistry, Chemistry, or equivalent.
• Minimum 6 years of GMP experience.
• Experience with analytical testing and equipment; writing reports, procedures, specifications, GMPs, and audits.
• Strong cell-based assay, qPCR, ELISA, analytical biochemistry/chemistry experience.

Responsibilities

• Lead visual inspection activities supporting product lot release.
• Execute assay qualification, method validation, studies, and tech transfer projects.
• Perform and review cell-based assays, ELISA, qPCR, immunoblot, and related testing.
• Conduct aseptic sampling and routine lab testing (pH, conductivity, osmolality, spectrophotometry).
• Serve as SME for testing methods and instruments.
• Provide guidance to Junior Analysts and Analysts.
• Review and author SOPs, test methods, protocols, and reports.
• Participate in regulatory inspections and cross-functional quality initiatives.

Skills

Quality Control

Analytical Testing

GMP

Cell-Based Assays

qPCR

ELISA

SOP Writing

Education

Bachelor's degree in Biology, Biochemistry, Chemistry, or an equivalent scientific field

Tools

qPCR Instrument

ELISA Plate Reader

Spectrophotometer

Job description

BioTalent is seeking a Lead Analyst, Quality Control to join our GMP biopharmaceutical team. You will lead analytical testing activities and coordinate assay qualification, method validation, and tech transfer projects for life-saving biologics.

This role requires a Bachelor's in Biology or Chemistry and at least six years of GMP experience, with strong cell-based assays, qPCR, ELISA, and analytical chemistry expertise.