高级新产品开发工程师

    • Songling, China

Site Name: Suzhou Plant Tech Industry Park
Posted Date: Jul 10 2020
Job Summary:
为满足新产品的上市计划,负责新产品试验过程的计划、实施、总结,为新产品的注册过程整理相关报告及资料;为新产品的上市过程进行工艺放大试验过程的计划、实施、总结。协助新产品开发主管及持续供应&新产品开发经理进行多项目管理。
RD产品转移工作:配合RD的项目开发工作,结合工厂实际,并协调工厂各部门的意见,确保研发产品在公司中试、放大工作顺利进行,保质保量地完成产品转移工作,并共同确保注册资料顺利提交,保证新产品按时上市;
新产品/新包装上市工作:与各部门配合,按不同市场的要求,负责新产品的全阶段开发工作,并协调新包装的开发工作,提交符合要求的注册资料,并保证产品按时上市

Key Responsibilities:
新产品试验过程

  • 对新产品从原、辅料选择,处方试验、制剂过程开发、包装开发等一系列为达到既定新产品质量、外观要求而进行的系统的工作。主要工作包括:试验用原、辅料的选择;试验方案的制定、执行、跟踪;试验过程关键工艺参数等内容的总结、分析、报告。稳定性评估及稳定性方案制定

注册资料准备
  • 总结注册批生产的批记录;
  • 按照注册要求总结注册批生产前的工艺研究过程以及注册批的工艺过程;
  • 汇总注册部需要的证明性文件(原料合法来源证明等);
  • 审阅递交前注册准备文件的准确性和合理性

新产品项目管理
  • 根据新产品的计划,定期跟踪各项任务的实施情况,根据实施进程的具体情况定期更新时间表,以保证各项目的如期推进或在一定理由的基础上更新时间表。

新产品 /新包装上市前准备
  • 负责新产品生产的规模扩大和工艺改进过程的方案设定、实施、跟踪;
  • 规模扩大工艺过程总结;
  • 负责新产品/新包装上市前的项目跟踪协调工作,保证产品顺利上市
  • 遵守公司有关EHS的政策和规定,并完成EHS相关工作。
  • 确保行为符合国家法律、法规政策的要求

工艺管理
  • 支持已商业化产品的生命周期内的管理,分析产品的工艺稳定性。
  • 进行工艺持续改进项目,提高工艺的稳定性、产品质量和工艺效率。提供技术工艺信息,协助SOI/SPI专员完成工艺规程和主批记录。
  • 维护物料和产品的技术标准,完成或协助标准文件的维护。解决生产中的技术问题,改进生产工艺,开发新路径。
Basic Requirements:
  • 要求有软胶囊相关研发\生产的经验
  • 药学相关专业本科以上; 制药专业知识,制药行业GMP专门知识,国家药品法规,劳动法、环保法等
  • 沟通和协调能力,具备项目管理知识,能运用有效工具对本岗位工作予以实施和独立解决问题
  • 能熟练掌握工作流程,熟练运用机器设备进行日常小试和大试,并且具备其它该工作所需的岗位技能。需要有软胶囊相关的研发,现场工艺改善,或者生产的经验;具备良好的英语能力,起草实验方案报告;
  • 项目管理能力:具备良好的项目管理能力,能负责项目的沟通、跟踪管理;
  • 沟通能力:具备良好的沟通,表达能力;和同事交流/向上级汇报工作时能做到没有沟通障碍
  • 持续改进:能够对本岗位工作提出有效改进建议,能够运用有效工具予以实施,能独立解决项目中的问题
  • 团队合作:对部门/小组的人员和各职位的工作内容有清晰的认识,能很好的和部门同事以及其他跨部门同事协同工作,具备团队意识及相互帮助的精神。具有较一定的多项目管理能力以及较好的内外部沟通能力
  • 人员管理:具备一定的管理团队的经验和技能


Why GSK?
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.

LI-GSK

Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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