Senior/Principal Scientist, LBA

Overview: A leading CRO is seeking an experienced bioanalytical scientist to join its Bioanalysis & Biomarkers group. This team supports global pharmaceutical and biotech partners by delivering high‑quality GLP/GCLP bioanalysis, method development, and biomarker services across both preclinical and clinical programs. This role provides scientific leadership on regulated bioanalytical studies, acting as a key partner to clients and ensuring successful execution of PK, ADA (immunogenicity), and biomarker assays.

What You'll Do: Design assay strategies and independently develop, validate, execute, and troubleshoot ligand‑binding bioanalytical methods (PK, ADA, biomarkers) under GLP/GCLP.Analyze, present, and interpret data for internal teams and external clients. Serve as the Principal Investigator, owning client interaction from study design and planning through execution, reporting, and data transfer. Ensure study timelines, deliverables, and quality expectations are consistently met. Act as Subject Matter Expert for LBA platforms, including ELISA multimode readers and Meso Scale Discovery (MSD/ECL).Write and/or review regulatory documents, validation protocols/reports, technical reports, and data packages. Provide day‑to‑day oversight of laboratory activities and mentor junior team members. Contribute to process improvements, operational excellence initiatives, and updates to SOPs, procedures, and work instructions. Maintain compliance with GLP/GCLP/GCP/GDP, EHS requirements, and organizational standards. Support additional responsibilities as needed.

What You Bring: Degree in a relevant scientific field (Biology, Immunology, Chemistry, Pharmacology, or related).Ph. D.: 4+ years industry experience Master's: 9+ years Bachelor's: 12+ years in Pharma/Biotech/CRO environments Strong hands‑on experience with GLP/GCLP bioanalysis. Demonstrated expertise in LBA method development and validation for PK, ADA, and PD biomarker assays. Significant experience with immunogenicity assay development, validation, and sample analysis is highly preferred. Familiarity with Watson LIMS and prior CRO experience are pluses. Proven leadership abilities-project oversight and/or people management. Ability to work independently with excellent attention to detail. Strong collaboration skills and the ability to meet timelines in a client‑focused environment. Excellent written and verbal communication.