制剂工艺研发项目负责人 重庆

月薪： 0.8-2万/月

该公司所有职位
  • 5-7年经验
  • 硕士
  • 招1人
  • 11-09 发布
  • 五险一金

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 5 years of experience in drug development in the pharmaceutical industry.5年以上药物制剂研发相关工作经验。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： 医药技术研发人员

联系方式

重庆市南岸区涂山路565号

公司信息

重庆医工院是由上海复星医药与重庆医药集团合资组建的主要从事化学合成药物、中西药制剂研究开发的综合性科研单位及产业化基地。拥有由国家新药审评专家、海外科学家、资深工程师构成的强大研发管理团队。公司建立了学科配套齐全的新药研发体系，拥有良好的科研设施，先进的检测、实验仪器，充足的工业化试验装备。    近二十年来完成国家“七五”、“八五”、“十一五”、“十二五”攻关项目、“863”计划项目及重庆市重点攻关项目、科技计划项目200余项，获得国家、省部级科技成果奖30余项。累计申请发明专利200余件，其中：PCT专利20件，国外专利27件，获得中国专利授权70件、国外专利授权14件。80%以上的科研成果转化为生产力，累计创造工业产值超过60亿元。被认定为***高新技术企业、***企业技术中心（复星医药所属）、重庆市创新型企业、重庆市化学制药工程技术研究中心。    面对未来的机遇和挑战，本公司将秉承“合作Cooperation、激情Passion、责任Responsibility、创新Innovation”的企业精神，坚持以创制具有自主知识产权的新药为主线，实施人才战略、创新战略、国际化战略。通过打造新药研发特色技术平台，建立仿创并重、规范化、专业特色突出、国际主流市场认可的新药研究开发体系与产业化试验实施体系，构建国内一流、与国际接轨、以医药技术研发为驱动力的高科技型企业。本公司坐落重庆市CBD（南岸区），交通、生活便利。现诚邀医药相关人才加盟，公司将提供良好的薪酬福利和培训发展机会，与您携手共创医工院更加辉煌的明天！联系人：杨老师　15922691855　　张老师　13996273616简历投递：①E-mail：hr@cpri.com.cn；② 51job、猎聘、智联、联英在线投递

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