Senior Scientist / Principal Investigator, Bioanalysis & Biomarkers

(GLP/GCLP · LBA · PK/ADA/Biomarkers)

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.