制剂研发项目负责人 杭州

月薪： 1.5-2万/月

该公司所有职位
  • 无工作经验
  • 博士
  • 招2人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 餐饮补贴
  • 通讯补贴
  • 出国机会
  • 年终奖金
  • 定期体检
  • 专业培训

职位描述

职位描述： Preferred Qualifications:职位要求：Education and Experience：背景及经历：Have a master degree or Ph D in pharmaceutical sciences or a related discipline.具有药学及相关专业硕士或博士学位。At least 6 years of experience in drug development in the pharmaceutical industry.6年以上药物制剂研发相关工作经验，其中国外经历不少于2年。Technical Skills:专业技能：Ideally has developed experience or education in oral drug delivery system and parenteral drug delivery system（e.g. tablet，injection and transdermal patch）口服给药系统及非肠道给药系统（如：片剂，注射剂，透皮贴剂等）相关研发经历及知识。Good knowledge of all regulatory guidance, standards and requirements pertaining to application writing worldwide (e.g. ICH, FDA, EMA)熟悉申报ANDA所需相关法律法规及指导原则（如: ICH, FDA, EMA）。Drug development know how and understanding of process development and how cGMP practices are applied to practice over entire process development cycle.能理解整个药物研发过程及在cGMP在研发周期中的应用。Have a broad functional knowledge of pharmaceutical sciences industry, with a clear understanding of drug development/commercial manufacturing of pharmaceuticals.对制药工业有深刻地认识，清楚地了解药物的研发及工业化生产。Highly developed project management skills with the ability to translate business/company objectives to relevant project goals and the ability to create detailed work plans with linked dependencies and identified critical path activities.有良好的项目管理技能，能为公司项目制订详细的研发计划，包括预算及关键线路。Previous experience leading a project team and demonstrated success with significant contributions to major milestones of project by applying a broad range of scientific/technical principles.曾经成功带领团队完成药物研发项目。Excellent interpersonal and organizational skills.优秀的组织及交际能力。Ability to collaborate with individuals at all levels between various groups and sites and in a matrix organization.能与各部门及团队成员间有效沟通。Ability to work independently without strong support.能在小公司环境下独立完成项目。Strong communication skills, both written and verbal to successfully articulate concepts and ideas.有较强的书面及口头表达能力。Job Responsibilities:岗位职责：Organization and execution of global research projects with accuracy and reliability, e.g. create experimental plans, conduct experiments, analyze results to draw meaningful conclusions, and productively collaborate with core groups.负责ANDA项目研发，如：制定试验计划，进行试验，分析试验结果并得出有效的结论，协调各部门间工作。Manage projects and provide scientific support for process development programs. Tasks include creating and maintaining the Project Schedules for early stage (pre-PoC) CMC programs; tracking deliverables and identifying critical path items gating to the major Decision Point milestones; drafting and publishing monthly reports on Project Team progress against the project schedule; and performing Project Risk Assessments on a routine basis with input from the key stakeholders on the Project Team.管理项目并对项目研发过程提供指导。包括预试验阶段制定及修改项目计划，跟进及报告项目关键路径及时间点，按照项目计划起草及发布项目进度月报，对项目进行风险评估。Performs data collection and analysis, discuss conclusions regarding progress of work, and effectively communicates information to supervisor in the form of discussions and reports.负责试验数据分析，结果讨论及试验跟进，并向上级报告试验结果。Provides support in the transfer of product formulations to internal and external production facilities.为项目公司内外转产提供支持。Lead and mentor writing ANDA application.负责ANDA申报书的撰写。Perform job responsibilities in compliance with cGMP, GLP and all other regulatory agency requirements.开展项目须符合cGMP，GLP及相关法规要求。 职能类别： 医药技术研发管理人员

联系方式

杭州经济技术开发区6号大街452号1幢2楼B区

公司信息

领业是一家立足中国和美国、面向世界的特色制药研发企业，我们专注于为全球各个国家和市场开发具有挑战性和创新性的特色药品（Bring Challenging Molecules to the Global Markets）。分别在中国杭州设立了创新研发中心和美国大波士顿地区设立了商务拓展及产品注册办公室。 领业的使命是将有挑战性的药物分子带向市场，我们的SoliTech？“一致性评价”解决方案为全球客户提供从原料药的晶型研究（盐型/晶型/共晶筛选、结晶工艺开发）、产品开发（处方制剂、分析方法）、直到获得产品批文（FDA GMP、注册法规）。 自2010年成立以来，领业已经服务200多家客户、研究200多个品种、年检测量3000多批次以上，专业规范的技术和及时准确的沟通为客户带来可靠的价值体验，也为领业同5家国内外企业建立的长期战略合作伙伴关系打下坚实基础。 领业团队在中国/北美/欧洲有十多年的产品创新及商务开发经验，我们致力于为全球各个国家和市场开发具有挑战性和创新性的特色药品，尤其是以新型缓控释和复方为主的505（b）2、以及有NTI、高变异或专利障碍等挑战性的仿制药。 领业是一个年轻的公司，整个管理团队带着他们在北美多年积累的知识和经验，努力在公司创造一个友善的工作环境，并帮助每一个员工在他的职业道路上发展。我们欢迎人才的加盟，在领业未来的画布上画上你们的颜色！

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