Principal Scientist- LBA

Top Quality Recruitment (TQR); Pleasanton (CA); On-site; USD 150,000 - 210,000; Full time

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

The Associate Principal Scientist - LBA will lead the development, validation, and execution of ligand-binding assays to support preclinical and clinical studies. This role requires strong scientific leadership, technical expertise in bioanalytical assay development, and cross-functional collaboration to support drug discovery and development programs in compliance with regulatory guidelines.

Key Activities

• Independently propose assay design and/or strategy, develop, validate, conduct, and troubleshoot bioanalytical methods, including PK, ADA (Immunogenicity) and Biomarker, for GLP/GCLP sample testing and data reporting. Present and interpret data internally and/or externally as needed.
• Serve as the Principal Investigator responsible for interaction with the client from the study design to scheduling, conducting, reporting, and transferring data. Ensure responsiveness to the client, timely delivery, and overall customer satisfaction.
• Serve as Subject Matter Expert (SME) for LBA (ELISA multimode reader & Meso-Scale Discovery (ECL)).
• Author and/or review key regulatory documents, validation plans and reports, laboratory data, and technical reports.
• Provide oversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence.
• Assist in establishing and improving policies, procedures, work instructions and SOPs.
• Understand and adhere to corporate standards regarding code of conduct, Environment Health & Safety (EHS), and GLP/GCP/GDP compliance.
• Perform other related duties as assigned.

Preferred Skills

• Experience with Watson LIMS and in the CRO environment is preferred.
• Supervisory experience in both project and talent (people) management is preferred.

Education and Experience

• PhD, M.Sc., M.A., B.A., in Biology, Immunology, Chemistry, Pharmacology, or other related scientific fields required, including a minimum of 4+(PhD), 9+(Master's) or 12+(Bachelor's) years of Pharma/Biotech/CRO experience.
• Hands-on experience and strong knowledge of GLP/GCLP bioanalysis.
• Experience in LBA-based method development and validation for PK, ADA (Immunogenicity), and PD Biomarker assays.

Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.

TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.

Accommodation for applicants with disabilities is available upon request.