About this opportunity
Top Quality Recruitment (TQR) lists this Principal Scientist- LBA opportunity in pleasanton, California. Review the employer’s description below for duties, qualifications and application requirements.
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.
#J-18808-Ljbffr
Worksite address
pleasanton, CA, 94566, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.