上海招聘

Responsibilities:

l  Hands on experience in qPCR based assay and ELISA based assay development, optimization and validation in QC lab environment.

l  Lead a group Scientist to perform routine test including in-process /release/stability testing of cell therapy product under cGMP environment.

l  Responsible for non-GLP bioanalytical project including sample analysis , summary report and documentation.

l  Drafting and review of experimental scheme, SOP and report.

l  Be responsible for assay trouble shooting and analytical method improvement when necessary.

l  Ensure Biochemical assay lab running effectively, compliance to cGMP requirement.

l  Participate in AD/QC lab investigations of OOS/OOT or deviation and implement CAPA.

l  Team member training, job assignment and performance management.

 

Qualification:

l  Master above, Major in cell biology/molecular biology/immunology/medicine or related.

l  5 yrs+ qPCR/ELISA assay of biologics QC related experience is a plus.

l  Familiar with machine operation of multimode reader and real-time PCR and data analysis.

l  Strong capabilities in assay development and validation design, in depth knowledge of methodology is preferred.

l  Strong executive ability, good laboratory organization and compliance management ability.

l  IND filings experience for gene/cell therapy product is preferred.

星德汉生物医疗有限公司是一家致力于免疫疗法研发与产业化的生物技术医药公司，总部位于新加坡。公司获得来自德国慕尼黑工业大学技术的独家授权，专注于利用患者自身免疫系统治疗病毒感染引起的疾病和癌症。公司在全球具备领先优势，並致力于在中国发展并开展临床研究，在上海浦东建立了中国首个研发基地。