Senior Scientist, Bioanalytical Compliance
Core
Lead compliance activities and support bioanalytical, biomarker, and immunogenicity programs across the full drug development lifecycle to ensure accredited laboratory standards.
Role type
Senior Scientist, Bioanalytical Compliance
Builds
Bioanalytical, biomarker, and immunogenicity programs for preclinical and clinical development
Domain
Biotherapeutics / Clinical Bioanalytics / Regulatory Compliance
Deliverable
physical/clinical work
Required skills
OECD GLP, ISO 17025, GCP, FDA/EMA guidelines, laboratory quality systems, assay development, validation, data integrity, audit/inspection management, cross-functional collaboration
Preferred skills
MSc or PhD in Immunology/Biomedical Sciences, 3+ years industry experience, emerging technologies/AI in regulated environments, scientific community engagement
Technologies
AI-enabled approaches, automation, digital solutions
Responsibilities
Lead compliance activities within accredited bioanalytical laboratory; Support laboratory accreditation, audits, inspections and quality management; Provide scientific expertise for bioanalytical and biomarker programs; Partner with cross-functional teams to deliver milestones; Contribute to assay development and validation; Promote innovation with emerging technologies; Represent company in scientific community
Seniority
Senior, hands-on IC with leadership responsibilities
