About the Job
China Gateway Biologics (Shanghai) Co., Ltd. (CGB) is the biologics division of ShangPharma Group. CGB specializes in providing integrated CRO and CMO services in biologic development and manufacturing. The person in this position will lead the Analytical Center & QC at CGB based in Zhangjiang, Shanghai. Main responsibilities include:
· Lead a team of scientists and associates to develop analytical assays and conduct assay validation and testing for therapeutic protein for various research and manufacturing stages.
· Define, implement, and manage the various quality control programs needed to ensure GMP/GLP and regulatory compliance.
· Establish SOPs and LIMS and ensure sample testing and testing reports completed in a timely manner to meet the demands of all projects.
· Manage and coordinate the activities of the department in support of biopharmaceuticals produced in the cGMP facility including: oversight of analytical (protein) and microbiological in-process, release and stability testing, the environmental monitoring and raw material programs; deviation investigation and guiding in potential CAPAs; draft and revise SOPs; staff training and development.
· Keep all required instrument and equipment calibrated, validated if needed, and maintained in good conditions.
· Hold regular communication with clients in written and oral formats.
· Write and review technical reports and regulatory submission files.
· Ability to manage multiple projects in parallel with different priorities
· Day-to-day team operation management.
· Ph.D. degree in chemistry, biochemistry, molecular biology, analytical science or other related fields is required.
· A minimum of 8 years of working experience in biopharmaceutical development
environment with good track record in analytical development and quality control is required.
· Experiences in international pharmaceutical companies are preferred.
· Oversee all analytical laboratory procedures and related testing, data review, trending, interpretation and reporting of results.
· Oversee analytical (protein) and microbiological in-process, release and stability testing and the environmental monitoring and raw material programs.
· Coordinate cross-functional, intra-group and inter-group work assignments and address scheduling conflicts.
· Provide guidance on the resolution of EMIs, deviations, OOS and CAPAs.