上海招聘

体外诊断试剂生产经理/总监:

职位职能: 体外诊断试剂生产经理/总监

岗位职责：

1．严格按照体外诊断试剂生产的要求建立和管理体外诊断试剂生产部门；

2．协助完成洁净厂房的设计、安装工作；

3．负责部门员工的操作技能培训；
4. 根据公司的要求制定生产计划，指导并带领生产团队按时完成生产任务；

5. 协调各部门之间的沟通与合作，及时解决生产中出现的问题；

6. 参与生产工艺的制定和优化，组织落实、监督调控生产过程各项工艺、质量、设备、成本、产量指标等；

7．负责生产部门员工的日常管理和工作评价；

8．其他公司安排的任务。

职位要求：

1．生物制药及相关专业，本科以上学历，具有多年核酸类体外诊断试剂生产管理经验；

2．熟悉医疗器械相关法律法规，熟知GPM生产标准和规范；有ISO13485管理经验；

3．熟悉体外诊断试剂生产质量考核体系，具有质量体系考核经验；

4．熟悉生产部门的运作和管理，拥有丰富的生产管理、成本控制、质量管理方面的经验；

5．熟悉实时荧光PCR等体外诊断试剂的生产工艺和生产规范并能制定适合的生产管理制度；

6．具有作业现场人员管理能力和一定的行政管理能力,有较强的团队领导力和带动力，良好的分析问题和解决问题的能力；

7．优秀的统筹计划、沟通协调能力、良好的分析解决问题、较好的语言和文字表达能力；

8．强烈的事业心和责任感，诚实正直；具有团队精神；

9．熟练使用各种办公软件，良好英语水平。

· Production Manager

· Director of Manufacturing

· Participation in formulating and administering company policy and developing long range goals and objectives. This includes the direction, focus, and visualization of activities in responsible departments to further the overall progressive goals and objectives and monitor their progress.

· Direct the company’s manufacturing activities to ensure maximum effectiveness is obtained for the production of quality products within specified time and budgetary guidelines.

· Accountable to ensure products meet or exceed customer quality standards and required schedules are met.

· Interface with Sales and Marketing to coordinate the production process for the introduction of new products.

· Directs manufacturing to ensure company facilities and equipment are adequately designed, build, and maintained. The emphasis will be on robust equipment/processes utilizing poke yoke techniques and quick change over. Likewise creative strategies to reduce labor cost, reduce scrap, and ensure a product free of defects.

· Oversee company wide procurement activities and direct the negotiations of major procurement contracts to provide proper cost, delivery, and quality commitments. The emphasis will be on furthering the world wide supply base to remain competitive. A strong working knowledge and background in sourcing products from Asia is a major plus. Ability to mentor and develop existing procurement employees is desired.

Other activities:

· Provide leadership in continuous improvement activities and successfully enable scalability to achieve our goals of meeting quality, cost, and delivery objectives.

· Create and implement new logistics models and processes that will drive all product capabilities to benchmark levels (industry best practices) and meet current and future customer needs on a global basis.

· Lead the development and implementation of policies, plans and practices regarding product supply/demand and delivery and authorizes the implementation of strategy and policies.

Qualifications:

· Extensive experience in delivering multiple complex system level products

· Bachelor’s Degree required. Masters Degree in Engineering discipline or MBA preferred

· Candidate will exhibit characteristics of a leader who is determined, results oriented, persuasive, and a strong communicator

· 10+ years of experience managing teams is required

· 10+ years of experience in a manufacturing leadership position

· Ability to lead and mentor staff to achieve significant results

· Ability to influence, negotiate, and gain commitment at all organizational levels

· Possess high professional ethics, good judgment, and the ability to take decisive action

· Superb communication (verbal and written) and interpersonal skills

· Experience developing safety and health programs compliant with OSHA requirements Salary commensurate with experience.

上海普洛麦格(Shanghai Promega)生物产品有限公司是美国普洛麦格公司全资拥有的外商独资企业。公司主要生产和销售细胞生物类、生物化学类、生物试剂盒类、临床诊断试剂盒类产品。公司依托美国普洛麦格总部的研发和技术优势，配备先进的生产设备和训练有素的技术骨干，确保公司的产品在全球市场上具有质量和成本优势，满足公司日益扩大的生产规模之需求。公司的战略目标是成为世界级的蛋白质产品、核酸标记物和分子生物学试剂盒的生产基地。
上海普洛麦格(Shanghai Promega)公司自一九九二年六月成立以来，历年都被认定为高新技术企业和 先进技术企业。公司自一九九七年起全面实行质量体系管理并于二〇〇〇年顺利通过了上海质量体系审核中心的认证，取得了ISO9001的质量体系认证证书，并连续十二年复审通过。二〇一三年又顺利通过了英国BSI ISO 9001:2008和ISO 13485:2003 质量体系认证，取得质量体系认证证书。二〇一四年又获得了上海市食品药品监督管理局颁发的医疗器械生产企业许可证。