Principal Scientist, LBA: Lead Bioanalytical Methods

Top Quality Recruitment (TQR)

Pleasanton (CA)

On-site

USD 150,000 - 210,000

Full time

2 days ago
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Job summary

Top Quality Recruitment (TQR) seeks an Associate Principal Scientist - LBA to lead development, validation, and execution of ligand-binding assays for preclinical and clinical studies in a regulated environment. The role requires strong scientific leadership, bioanalytical expertise, and cross-functional collaboration.

Responsibilities include strategy proposals for PK/ADA/biomarker assays, client interaction, SME duties for ELISA and MSD, regulatory documentation, mentoring staff, and SOP/EHS

Qualifications

  • PhD/MSc/BA in biology or related field with pharma/biotech/CRO experience.
  • Hands-on GLP/GCLP bioanalysis knowledge and LBA method development/validation.
  • Experience in PK, ADA (Immunogenicity), and PD Biomarker assays.

Responsibilities

  • Lead design, development, validation, and troubleshooting of bioanalytical assays (PK, ADA, Biomarker).
  • Interact with clients from study design to data delivery, ensuring satisfaction.
  • Serve as SME for LBA platforms including ELISA multimode reader and MSD.
  • Author and review validation plans, reports, and regulatory documents.
  • Oversee laboratory operations and mentor junior staff.
  • Help establish SOPs and GLP/GCLP/EHS compliance.
  • Perform other duties as assigned.

Skills

Bioanalytical leadership
Assay development
Cross-functional collaboration
Regulatory compliance
Data interpretation
Mentoring

Education

PhD in Biology/Immunology/Chemistry/Pharmacology
MSc in related field
BA/MA in related field

Tools

Watson LIMS
ELISA multimode reader
Meso-Scale Discovery (MSD)

Job description

Top Quality Recruitment (TQR) seeks an Associate Principal Scientist - LBA to lead development, validation, and execution of ligand-binding assays for preclinical and clinical studies in a regulated environment. The role requires strong scientific leadership, bioanalytical expertise, and cross-functional collaboration.

Responsibilities include strategy proposals for PK/ADA/biomarker assays, client interaction, SME duties for ELISA and MSD, regulatory documentation, mentoring staff, and SOP/EHS

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