• 无工作经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述: Summary?Lead new product development and formulation development.?Conduct research or design strategies to achieve the technical vision for a new or improved product/process/method or to prove a new theory, applying a solid understanding of theories/practices including those from other disciplines outside the primary area of expertise.?Familiar with cGMPs, ICH guidelines and other regulatory framework for drug/solution development. Strong domain knowledge of sterile dosage form design including formulation development, container interactions etc.Essential Duties and Responsibilities.?Provide pharmaceutical development technical leadership in the areas of CMC development, especially formulation development.?Participate in multifunctional project teams and collaborate with various functions (manufacturing, marketing, quality, regulatory, medical affairs).?Under direction of senior scientific staff, create innovative products/ processes/methods through novel combinations of expertise within the organization.?Independently plan and execute a series of designs that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines.?Supervise production of development batches at lab and pilot scale. Perform critical review of data obtained and issue protocols & reports.?Contribute to the preparation of CMC section of regulatory submissions and scientific package used to support meetings with regulatory agencies.?May provide training and supervision to junior members within the discipline. Routinely provide advice and assistance to team members regarding unique problems.?Provide support to develop effective budget and schedule.?Review relevant literature and patents concerning projects.?Reach conclusions based on research analysis and incorporate recommendations into larger projects. Apply advanced techniques to solving difficult problems.?Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.?Maintain focus on meeting both external and internal customer expectations.?Maintain laboratory and office area in compliance of GXP, EHS and 6S requirements.Qualifications.?Possess working knowledge of sterile dosage product development.?Proficient in chromatographic (HPLC/UPLC) and spectroscopic analyses.?Possess technical, writing, and computer skills.?Must be able to able to carry out strategy and vision set by upper management and be able to communicate the vision to more junior associates.?Ability to make routine and some less routine decisions independently.?Can effectively communicate with internal and external customers.?Demonstrates flexibility and the ability to shift gears between projects comfortably.?Ability to communicate in English and Chinese.Education and/or Experience.?Bachelor's degree in Chemistry, Chemical Engineering, or Pharmaceutical Sciences with at least 15 years experience, or MS with at least 8 years, or PhD with at least 3 years in relevant discipline required. QSR research experience is essential and GMP experience useful.?Experience in product development. Familiar with ICH guidelines and knowledge of sterile dosage form design.?Leadership of technical teams and project management experience is desirable. 职能类别: 生物工程/生物制药

联系方式

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公司信息

特别注明:苏州百特的所有招聘岗位仅通过圆才网和前程无忧网进行发布和收集简历!苏州百特的联系地址只有一个,白榆路27号。 每一天,百特影响着数以百万计的生命,我们凭借必要的医院和肾科产品与服务应对重大健康需求。在全球,几乎每个医院的每个科室,乃至每一楼层,都能发现百特产品与疗法的身影。同时,百特也出现在诊所和患者家中。 Every day, Millions of lives relay on Baxter, Our products and service are essential building blocks of healthcare. Baxter products and treatment are found almost in everyplace, in every hospital at every Department even on every floor. Meanwhile, Baxter is there, not only the clinic but also our patient home. 百特于上世纪80年代来到中国,是最早进入中国医疗市场的大型跨国医疗企业之一。秉承“拯救并延续生命”的企业使命,百特专注于协助提升医疗标准、扩大医疗可及性和回馈社会等关键性工作,为中国患者的生命和生活质量做出有意义的贡献,助力中国医疗事业的可持续发展。 In the 80s Baxter has come to China which is one of the earliest multinational medical enterprise, Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations, also delivering contribution to our patient and their Quality lives meanwhile it will be supportive of sustainable development for Chinese medical treatment cause 苏州百特医疗用品有限公司成立于1995年, 是百特在中国建立的第一家独资工厂,主要生产静脉输液袋、腹膜透析袋及相关组件,以用于静脉输注及腹膜透析治疗。我们始终严格执行中国质量管理体系,确保我们的产品以最高质量和安全标准为患者及医护人员服务。目前, 560多名员工正运用最创新和先进的制造技术,为中国大陆、中国台湾、新加坡、澳大利亚、菲律宾及泰国等国家和地区的客户提供优质高效的医疗产品,为依赖于百特产品的患者带去有意义的改变。 Suzhou Baxter healthcare co., LTD is founded in 1995, This is the first sole plant in China. Baxter Suzhou produced venous transfusion container, PD bag and other related components which used in PD and venoclysis treatment, In order to provide the high-quality product, and let our customers using safety. Baxter Suzhou not only follow up the quality policy of Baxter headquarters, but also carry out the quality management system of China strictly as well ,At present, more than 560 employees are using the latest manufacturing technology to provide high quality medical products for customers comes from China Taiwan, India, Australia and the Philippines. 我们的理念是注重结果、客户导向;我们的价值观是正直诚实、坦诚沟通、承责力行;我们的激励方式是鼓励创新、奖励优秀。百特致力于成为危重治疗领域的领先企业,期盼更多优秀人才的加入,我们承诺为您提供充满活力的工作和成长环境,与百特共筑未来!

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