北京招聘

?Manage overall product QC, including physiochemical, biochemical and cellular function analysis group.
?Lead QC method transfer, method validation and continual method performance monitoring.
?Lead QC submission document preparation for IND and NDA.
?Manage biologics stability center and lead study design, execution and data application for routine stability, in-use stability and shipping stability, and other exploratory studies.
?Lead biologics specification setting and updating.
?Lead release and stability comparability study.
?Lead reference standard and critical reagent management.
职位要求：
?Experienced and deep understanding of biologics analytical method development, method validation/transfer and relevant regulatory requirements.
?Experienced and good understanding of biologics potency assay, comparability, compatibility and in-use stability, cell bank characterization, leachable and extractable study, stability, specification setting, expiry dating, and other CMC regulatory and compliance strategies.
?Experienced and deep understanding of ICH Q series, GDP, Data integrity, and GMP requirements.
?Well-educated and broad-minded in both specific area and general science.
?Good communication skills in both Chinese and English.

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。