Scientist – Analytics, Technical Operations
Core
Lead analytical method development, validation, and transfer for life science, diagnostics, and clinical products in a regulated biotechnology environment.
Role type
Senior Scientist (Analytics, Technical Operations)
Builds
Analytical methods and quality control processes for product release and in-process controls
Domain
Biotechnology / Life Sciences / Diagnostics / Clinical
Required skills
Analytical method development, method validation, technology transfer, statistical data analysis, OOS/OOT investigation, experimental design, regulatory compliance (ISO 13485)
Preferred skills
Technology transfer experience, QC investigation support, ISO 13485 knowledge
Technologies
Statistical tools, analytical instrumentation
Responsibilities
Develop and optimize analytical methods for product release and raw-material testing; Design and execute feasibility, stability, and validation studies; Lead analytical method transfer between sites and departments; Provide scientific support for OOS/OOT investigations and CAPA; Analyze complex experimental data using statistical approaches; Collaborate on cross-functional new product development projects.
Seniority
Senior, hands-on IC
