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3-4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）?Supervise the activities of all QC Microbiology laboratory personnel, and act as the back-up for the Sr. Manager, QC Microbiology as required.?Plan, schedule, and assign work to the laboratory personnel.?Ensure that reports and data for assigned laboratory work are completed and submitted in a timely manner.?Supervising and coordinating the activities of the QC Microbiology analysts engaged in microbial testing and analysis for CMAB and CMAB clients.?Provide technical support and troubleshooting for issues identified internally and externally.?Implements methods and procedures for components, raw materials, in-process, bulk DS, finished DP, stability, transfer, method development/qualification, and cleaning validation.?Mentor and train the QC staff, evaluate performance and provide coaching and opportunities for staff growth and development.?Communicates department objectives and metrics (KPIs).?Participate in internal and external audits identifying appropriate actions and corrections providing timely response to assigned actions.?Support and participate in the identification, evaluation, and prioritization of continuous improvement activities.?Oversee routine equipment maintenance and calibration activities of department equipment.?Able to perform review of procedures suitably qualified and trained on.Job Requirements/工作经验?B.S. (preferably Microbiology or Biology) plus a minimum of 3 years in a quality control and compliance function for the manufacture of therapeutic biologics.？1 or more year, experience as a supervisor in a quality control/EM function is preferred.?Experience in a regulated biopharmaceutical manufacturer with exposure to facility start-up.?Solid knowledge in QC Microbiology related methods including, but not limited to:？Sterility Assurance？Bioburden (analysis and identification) for products, materials, etc.？Endotoxin？Safety testing as required?Solid 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.?Experienced and active participation in a robust change management system:？Document Management？Change Control？CAPA and Deviation？Training?Highly 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.?Strong prioritization and organization skills.?Detail oriented, flexible, self-initiative. 职能类别： 药品生产/质量管理 质量管理/测试主管(QA/QC主管)
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。
