Lead Principal Scientist, Bioanalytical LBA & PK/ADA

Top Quality Recruitment (TQR); Pleasanton (CA); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Equal opportunity employer

Disability accommodation available

Job summary

Top Quality Recruitment (TQR) seeks an Associate Principal Scientist – LBA to lead development, validation, and execution of LBA assays for preclinical and clinical studies. You will provide scientific leadership, cross-functional collaboration, and ensure GLP/GCLP compliance across programs.

You will act as PI with client interaction, SME for LBA technologies, and mentor staff while improving operational excellence and SOPs within a dynamic CRO environment.

Qualifications

• PhD/MSc/MA/BA in biology-related fields with pharma/biotech/CRO experience
• Hands-on GLP/GCLP bioanalysis
• LBA-based method development and validation for PK, ADA, and PD biomarkers

Responsibilities

• Propose assay design/strategy, develop, validate, conduct, and troubleshoot bioanalytical methods for GLP/GCLP testing.
• Serve as Principal Investigator, interface with the client from study design to data transfer and scheduling.
• Act as SME for LBA (ELISA multimode reader & MSD).
• Author/review regulatory documents, validation plans, reports, and lab data.
• Provide lab oversight, mentor junior staff, drive process improvements.
• Develop and update SOPs, policies, and working instructions.

Skills

Bioanalytical assay development

LBA ELISA & MSD

Leadership

Regulatory compliance

Cross-functional collaboration

Education

PhD in Biology/Immunology/Pharmacology

MSc in Biology/Immunology/Pharmacology

BA/BS in related field

Tools

Watson LIMS

Job description

Top Quality Recruitment (TQR) seeks an Associate Principal Scientist – LBA to lead development, validation, and execution of LBA assays for preclinical and clinical studies. You will provide scientific leadership, cross-functional collaboration, and ensure GLP/GCLP compliance across programs.

You will act as PI with client interaction, SME for LBA technologies, and mentor staff while improving operational excellence and SOPs within a dynamic CRO environment.