-
8-9年经验 -
本科 -
招1人 -
12-02 发布
- 五险一金
- 补充医疗保险
- 员工旅游
- 餐饮补贴
- 通讯补贴
- 专业培训
- 出国机会
- 股票期权
- 年终奖金
职位描述
职位描述： SummaryThis position administratively and technically manages the sterile filling operations at CMAB. Ensures that established GMP and all other requirements of CMAB Quality systems are met. Ensures that scheduled activities and budgeted production volumes and goals are met. Ensures appropriate training standards for the operations are established and personnel are trained appropriately. Ensures lowest possible cost of goods in compliance with existing rules and regulatory requirements.Key RequirementsoManage filling operations by directing the production activities on a daily basis. Ensures scheduled activities are performed as planned.oEnsure GMP compliance and meets requirements of CMAB quality systems.oEnsure production efficiencies are monitored and action taken to lower variable standard costs.oManage the administrative aspects of the group by ensuring the preparation of performance plans, job descriptions, and conducting employee performance reviews. This also includes hiring, rewarding, and disciplining staff as required; providing direction for professional development; maintaining an environment that fosters teamwork; and assigning responsibility and accountability at proper levels.oPrepare expense and headcount budgets. Ensure budget targets are met while providing production operations with adequate resources in facilities, equipment, and personnel to meet customer demands.oSupport the company’s safety program to maximize safety awareness and provide a safe work environment. QualificationsBS/BA in Physical, Biological, Chemical, or Production Related Science with 8 years relevant experience required.Fluent English skill (Reading, Writing, Speaking/Listening) to allow direct communication with client and regulatory agencies. 职能类别： 生物工程/生物制药 生产总监
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。
