Senior Specialist Data Review - Biologics (Large molecules)
Core
Review laboratory data for accuracy, clarity, and adherence to GMP/GLP regulations to ensure client data quality.
Role type
Senior Specialist Data Review (Biologics/Large Molecules)
Builds
Quality-assured analytical data for pharmaceutical and life sciences clients
Domain
Life Sciences / Biologics / Pharmaceutical Testing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Complex calculations, GMP/GLP compliance, Analytical techniques (Ligand binding, ELISA, Gel electrophoresis, Proteomics, Flow Cytometry, TEM, PCR, cell culture), SOP development, Technical advising, Regulatory knowledge (USP/EP)
Preferred skills
LIMS, Electronic Notebook, Coaching/mentoring
Technologies
Excel, Word, Access, Outlook, LIMS, Electronic Notebook
Responsibilities
Review scientific data including standard preparation, calibrations, methodology, QC, and sample data; Verify data quality and compliance with industry regulations; Diagnose and solve problems in professional area; Serve as technical advisor for analysts regarding QA/QC; Write or revise SOPs; Communicate findings and compliance concerns to internal clients.
Seniority
Senior, hands-on IC
