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As a Principal Scientist in Physicochemical Analysis, you will independently lead advanced method development, validation, and characterization for biologics (mAbs, ADCs) using core techniques including HPLC, UPLC, LC-MS, CE, and ICIEF. You will drive CMC compliance by designing complex studies (CQA assessment, comparability, stability), interpreting data, and preparing high-quality technical/regulatory documents to support global filings. This senior role requires 8+ years of innovator pharma experience, strong cross-functional leadership, and expertise to mentor teams and solve high-impact analytical challenges.
Job Responsibility:
Design and perform analytical support to biologics development from early to late stage
Analytical method development, transfer and troubleshooting for product quality control and stability study
Draft protocol/report and execute study to support IND/NDA filings
Participate in projects as ARD subject matter expert and provide professional guidance whenever needed
Requirements:
A Master’s degree in Analytical Chemistry, Pharmaceutical Sciences or a related field is required, with a strong technical foundation in physicochemical analysis
Profound expertise in key analytical techniques including HPLC, UPLC, LC-MS, CE and cIEF for biologics and ADC characterization is highly essential
The candidate should have 8+ years of progressive CMC experience in biopharmaceutical companies, with a proven record in method development, regulatory compliance and project leadership