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1年经验 -
本科 -
招1人 -
11-09 发布
职位描述
职位描述： Principal Duties and Responsibilities/主要职责（包括但不限于）?Ensure that all samples and ongoing projects in QC Microbiology are executed to plan and in compliance with approved protocols, procedures.?Execute all assigned microbial analysis as assigned by the department supervisor and manager in a timely manner.?Provide technical support and troubleshooting for ongoing investigations as assigned internally and externally, as required.??Implement methods and procedures for components, raw materials, in-process, bulk DS, Finished DP, stability, transfer, method development/qualification, or other as required.?Support internal and external audits identifying appropriate actions and corrections providing timely response to assigned actions.?Participate in the identification, evaluation, and prioritization of continuous improvement activities.?Perform and/or oversee routine equipment maintenance and calibration activities of department equipment.?Able to perform peer review of procedures suitably qualified and trained on.?Perform routine trouble shooting on qualified and related sampling and testing methods.?Participate and support in analytical method transfer and qualification following approved protocols.Job Requirements/岗位要求?B.S. (preferably Microbiology or Biology)？Preferred at least 1 year experience in a Quality Control Microbiology or related area supporting the manufacture of a cGMP regulated clinical or commercial therapeutic biologic.?Experience in a regulated biopharmaceutical manufacturer with exposure to facility start-up.?Knowledge in QC Microbiology related functions including, but not limited to:？Sterility Assurance？Bioburden (analysis and identification) for products, materials, etc.？Endotoxin？Safety testing as required?Awareness in Gowning qualifications for aseptic operations?Knowledge of Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP) encompassing documentation and operation of pharmaceutical facilities manufacturing therapeutics for clinical or commercial purposes in accord with international cGMP standards.?Understanding of mAb development, manufacturing, and analytical process.?Ability to understand and actively participate in a robust change management system:？Document Management？Change Control？CAPA and Deviation？Training?Skilled in computer system and database operation.?Ability or willingness to investigate and solve complex technical problems?Good communication skills in Chinese and English to engage with personnel from multiple disciplines and experience bases across the operations organization.?Prioritization and organization skills.?Detail oriented, flexible, self-initiative. 职能类别： 化学分析测试员
联系方式
东平街188号
公司信息
苏桥医药（苏州）有限公司是一家致力于抗体及融合蛋白类生物药物的研发、工艺开发、及中试生产的高科技企业，服务范围全面覆盖临床前研究、临床研究、及商业化生产阶段。总投资额为4,640万美元。 苏桥医药是苏州生物纳米科技园（BioBay）重点扶持的企业之一。苏桥在园区内的建造面积共占地7,000平方米，目标产能1期实现69批次，2期实现92批次。 苏桥将严格遵守国际主流药品监管机构的质量标准，包括CFDA、USA (21-CFR) 、EMA (Eurdralex)、PIC/S以及 WHO。苏桥交付的生产样品能够满足客户在全球多个国家临床试验申请的CMC要求。
