高级新产品开发经理
赫力昂(苏州)制药有限公司
- 江苏省苏州市吴中区
- 长期
- 全职
- Bachelor or above education in pharmaceutics, chemistry or related background.
- At least 10 years' experience in pharmaceutical manufacturing environment. Good process understanding and analytical skills, especially on solids and liquids. Good knowledge and understanding of cGMP and regulatory requirements.
- Skills on coordination, communication, organization, comprehensive judgement and problem solving; Familiar with office software and ERP application. Good oral and verbal English.
- Establish Suzhou site new product/business strategy:
- New business exploration:
- Implement globally recommended methodology to make best use of limited resource for the optimized outputs.
- New product development:
- Apply the basic principles of DOE flexibly to design related experiments for new product development, qualification and validation. Correctly apply data analysis tools to statistically analyze the acquired data in experiments to provide convincible evidence for application.
- New market expansion:
- Initiate, plan, implement, control and monitor the overall launch process post-approval, including demand confirmation on first supply, package development, export filing, preparation on raw/packaging material, documents and system before manufacturing, manufacturing, analytical tests, dispatch, and etc.
- Product lifecycle management:
- Responsible for communication with related departments internal and external, ensure the accuracy, punctuality and effectiveness of delivered information.
- Product safety monitor:
- Responsible for providing evidence to the safety label claim and investigate any safety complaints and concerns.
- Compliance:
- As per the requirements of procedure, proceeds regulatory impact evaluation on material to be developed, fully implement follow up actions to effectively avoid the risk of compliance.
- Team Management and Development: Provide coaching to subordinators and make career development plans for them to build a high performing team.
- Decision making and autonomy: Significant or long term decisions are proposed with rationale to SLT for final endorsement.
- Leadership: Prepare for and manage changes that impact site business.
赫力昂苏州工厂--惠氏制药有限公司成立于1991年7月,累计投资超过2.3亿美元,两厂区占地总计超110亩,共有员工超900人。主要产品有钙补充剂,多种维生素等非处方药。公司拥有按GMP标准建造的洁净厂房和世界先进水平的生产设备和技术。主要产品有钙补充剂、多种维生素、抗感冒咳嗽药、抗生素等多种处方药和非处方药,共计39种产品209个产品规格。除了满足国内市场的需求,部分产品已大量出口亚太地区以及拉丁美洲等12个国家和地区。公司采用全球一流的质量管理制度和保证体系,其质量管理水平在GSK全球供应集团名列前茅。自1998年至今,公司以优异成绩顺利通过了二十多次国内、国外GMP审查并获得认证,为产品质量提供了强有力保障。苏州新厂位于苏州市吴中经济技术开发区吴淞江科技产业园,于2018年5月获得商业生产批准。新厂一期占地约70亩,投资近1亿美元,主要生产钙尔奇、善存系列产品,新厂预计增加产能38亿片/年。新厂设计秉承了绿色环保、高效节能、可持续发展的理念,并历经层层严苛审核, 在2017年“国际绿色建筑大会”上, 荣获了LEED-NC(新建筑能源和环境设计先锋奖) 的铂金认证,成为全球制药行业首个获得该认证的园区新工厂!近期,新工厂又获得了国际工程制药协会(ISPE)2018年设施可持续发展大奖。基本信息公司名称赫力昂(苏州)制药有限公司所在地苏州吴中区投资方Haleon所属行业制药/生物工程企业类型外商独资、外企办事处投资规模5000万人民币地址苏州市宝带西路4号
O・HR 圆才