Lead Analyst, Quality Control

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

Support the Quality and Release of Life-Saving Biopharmaceuticals

Ideal opportunity for experienced Quality Control professionals with strong analytical testing expertise in GMP biologics manufacturing environments

Are you passionate about quality control, analytical testing, and biologics manufacturing?

We're looking for a Lead Analyst, Quality Control to join a growing Quality Control team supporting manufacturing, validation, process development, and stability studies in a GMP environment.

What You'll Do

• Lead and coordinate visual inspection activities supporting product lot release
• Execute assay qualification, method validation, special studies, investigations, and technology transfer projects
• Perform and review cell-based assays, ELISA, qPCR, immunoblot, electrophoresis, and other analytical testing activities
• Conduct aseptic sampling and routine laboratory testing including pH, conductivity, osmolality, and spectrophotometry
• Serve as a Subject Matter Expert for multiple testing methodologies and laboratory instruments
• Provide guidance and technical support to Junior Analysts and Analysts
• Review, revise, and author SOPs, test methods, study protocols, reports, and specifications
• Participate in regulatory inspections, continuous improvement initiatives, and cross-functional quality activities

What We're Looking For

• Bachelor's degree in Biology, Biochemistry, Chemistry, or an equivalent scientific field
• Minimum 6 years of relevant hands-on experience working in a GMP environment
• Experience with analytical testing and equipment, writing reports, procedures, specifications, GMPs, and regulatory audits
• Strong Cell-Based Assay, qPCR, ELISA, Analytical Biochemistry and/or Chemistry experience

Hourly Rate: $46.15 - $57.69 per hour

Additional compensation and benefits package available

Please Note

On-site in Tustin, CA

Full-time Quality Control laboratory position

Schedule is Monday through Friday, 8:00 AM to 5:00 PM

Ability to work overtime and/or weekends when necessary

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