EPM Scientific · 5 days ago
Senior/Principal Scientist, LBA
EPM Scientific is a leading CRO seeking an experienced bioanalytical scientist to join its Bioanalysis & Biomarkers group. This role provides scientific leadership on regulated bioanalytical studies, ensuring successful execution of PK, ADA, and biomarker assays for global pharmaceutical and biotech partners.
Responsibilities
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
Qualification
Required
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
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
Preferred
Significant experience with immunogenicity assay development, validation, and sample analysis is highly preferred
Familiarity with Watson LIMS and prior CRO experience are pluses
Company
EPM Scientific
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Funding
Current Stage
Late StageRecent News
BioSpectrum Asia
2023-12-23
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