1.负责实施项目的处方筛选、工艺优化、包材相容性、制剂稳定性考察及中试规模生产;
2.协助参与生产工艺交接和研发产品的放大生产、工艺验证工作;
3.负责按照要求做好原始记录并撰写研究报告;
4.负责承担的处方筛选、工艺研究等相关申报资料的撰写;
5.负责制剂实验室和设备的维护管理;
6.按时完成上级安排的其他工作任务。
1.药剂学、制药工程、药学及相关专业,全日制本科及以上学历,可接受应届生,有工作经验者优先;
2.掌握文献检索、资料查询的基本方法和较强的英文文献阅读能力;
3.了解制剂研发相关的法规和技术指导原则;
4.具有团队合作精神和良好的沟通协调能力,工作细致,有责任心。
1. 根据研发项目进度,进行分析方法的开发、验证;
2. 协助制剂进行处方筛选的分析研究和稳定性研究;
3. 负责协助撰写质量研究部分方法学的建立,实验方法的设计;
4. 对试验数据进行汇总、分析,并负责撰写相关的注册申报资料,协助现场核查;
5. 负责仪器设备的维护和保养;
6. 按时完成领导交办的其他工作和任务。
1.药学、药物分析分或分析化学相关专业,全日制本科及以上学历,有工作经验者优先,有液体制剂分析经验优先;
2.熟悉 HPLC、GC、UV等分析仪器的使用、维护和保养;
3.有较强的文献检索能力和英文文献阅读能力;
4.具有较强的药学或化学分析理论知识,较强的分析问题、处理问题的能力,团队合作精神和良好的沟通协调能力,工作细致耐心,有责任心。
1、迅速理解研发项目需求,及时调整工作重点。
2、把握实验进度,安排本人和组内(10人左右)其他成员的合成任务。、
3、设计分子的合成路线。
4、检查合成报告,深度解析分析数据。
5、撰写项目相关专利。
6、负责实验室日常管理,监督安全规范的执行情况。
1、有机化学专业,硕士或博士学历。
2、有五年以上工作经验。
3、实验操作严谨,规范,可重现。
4、精通一维和二维核磁的解析。
5、能从机理上分析反应失败的原因。
6、有培养新员工的经验。
7、具备英文文献的阅读能力和英文专利的撰写经验。
1.接受药化或工艺项目的研发任务。
2.完成有机合成化学反应和纯化工作。
3.分析实验结果(TLC,LCMS,NMR).
4.撰写实验记录和合成报告(中英文)。
5.遵守实验室安全规范。
6.遵守知识产权保护相关要求。
1.有机化学或相关专业本科或以上学历,愿意长期从事合成工作。
2.具备一定的动手能力。
3.有意愿在上海长期发展。
1、负责制剂部的管理工作,包括人员和团建建设、在研项目管理、合规性管理和实验室管理等;
2、负责创新药制剂处方前研究、处方筛选制剂工艺放大、技术转移、为生产提供处方和工艺规程,解决项目过程中出现的处方/工艺/放大等问题,推动项目顺利开展;
3、熟悉NMPA和FDA的各项相关法规,按注册法规要求、ICH相关要求组织新药的研发工作,负责申报资料的整理、归纳、汇总、原始记录、CTD资料的撰写及审核;
4、负责培养和建设专业的制剂研发团队,组织部门的培训和考核工作;
5、负责组织和优化制剂部的各项规章制度,并监督执行;
1、硕士及以上学历,药剂、药学、制药等相关专业,有七年及以上的制剂研发经验,5年以上的研发管理经验,有眼科制剂研发能力的优先;
2、有较强的主动学习能力,理论知识基础扎实,对制剂研发,剂型改进、工艺放大、分析研发有一定经验和深厚的技术功底;
3、熟悉药品研发注册的相关政策和法规、国家新药审评技术要求及审评动向,熟悉申报资料的撰写;
4、具备良好的英语读写能力,能够熟练的查阅各种文献,翻译相关文献资料;
5、对工作具有高度的责任心,能够承受较大工作压力,具有良好的沟通、协调能力和团队管理能力。
1、制剂部分的文献调研、处方工艺设计及研究、稳定性研究和相关放大等工作;
2、负责小试研究到中试生产的转化,及工艺交接或动态生产的工作;
3、及时解决对小试研究、中试生产中遇到的常见问题;
4、相关专利药的制剂技术规避,并能够撰写发明专利;
5、撰写注册申报资料;
6、维护和管理制剂研发相关设备,保证设备正常使用;
7、按时完成上级领导交办的其他工作任务。
1、具有团队合作精神,喜欢从事研发工作,工作细致,有责任心;
2、本科以上学历,三年以上工作经验,药物制剂等相关专业;
3、从事过制剂处方研究,具备制剂生产、研发等相关工作经验者优先。
Responsibility
1. Responsible for establishing and managing in vitro bioassays of drug discovery projects, including but not limited to literature research, assay method & plan proposal.
2. Responsible for establishment of emerging new technical platforms.
3. Responsible for managing CRO companies of biology related projects, including selecting high quality CRO, timely communication to ensure the expectation for collaboration are met.
4. Team management and training junior scientists.
Requirements
1.Ph.D in immunology, biochemistry, cell biology and related majors with >4 year experience on bioassays in industry, biotech or CROs;
Capable of independent discovery research, and capable of leading a team.
2.A good learner for new drug discovery field and emerging new techs.
3.Intensive in vitro biochemical and cellular bioassay experience;
4.Familiar with common bioassay methods like ELISA, TR-FRET, ALPHA, FP, FACS, In-cell western etc.
5.Experience on ocular drug discovery will be a plus ; Experience on high-throughput screening is a plus;
6.Fluent oral and written communications skills in English;
7.Strong sense of responsibility. Good communication skills and team-oriented.
Serve as Sr. Clinical Project Manager for international projects Phase I, II, III, IV for Bio Pharmaceutical & Medical Device projects, according to ESTERN Medical Standard Operating Procedures, ICH Guidelines and GCP with total responsibility.
Responsible for the successful conduct of assigned projects.
Serve as Project Manager for assigned business development opportunities.
Liaise with senior management in the Delivery and Service Centers to ensure adequate resources are available for assigned projects.
Responsible for on time, on-budget provision of client deliverables for assigned projects.
Education / Qualifications:
Required:
University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
Detailed knowledge of financial control procedures
Thorough knowledge of project management processes.
Thorough knowledge of time and cost estimate development.
Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
Excellent English and also preferably knowledge of some mid level Spanish or Portuguese language with superb grammar skills both written and verbal.
Broad knowledge of drug development process and client needs.
Preferred:
Masters or other advanced degree.
Detailed knowledge of ESTERN Medical and the overall structure of the organization.
Basic knowledge of ESTERN Medical sales and business development strategies and procedures.
Thorough knowledge of ESTERN Medical S.O.P.s
Experience Required:Minimum of seven (7) years relevant clinical research experience in a pharmaceutical / medical device company/CRO, including at least four (4) years of full project management responsibility.
In lieu of the above requirement, candidates with > five (5) years supervisory experience in a heath care setting and > five (5) years clinical research expe
现在申请Reporting directly to the VP of Ophthalmology and based in Shanghai.
Function as medical expert on one or more VivaVision clinical development programs.
Job Responsibilities
Lead the development and implementation of a clinical research plan
Provide medical and scientific expertise into clinical development and protocol planning activities
Serve as expert medical and scientific point of contact for regulatory and ethics committee interactions
Plan and participate in data analyses and creation of key study-related outputs such as clinical study reports and publications
Lead the development and implementation of a clinical research plan
Identify and propose projects to senior management for approval
Assist VP of Ophthalmology Research in prioritizing and allocating resources
Leverage external research collaborators as needed
Investigate, create, and/or develop new methods and technologies for project advancement
Assist in securing intellectual property, including detailed descriptions for patent filing and/or proof of concept work, as appropriate
Minimum Qualifications
PhD in a relevant scientific discipline with 5 years’ industry experience
Expert knowledge of scientific principles and concepts
Significant knowledge of ophthalmic disorders
Excellent oral and written communication skills
Ability to work in a team-oriented environment but also be a self-starter, internally motivated, with the ability to work independently to drive the research forward
Scientifically rigorous, highly organized, with significant attention to detail
Preferred Qualifications
PhD + Post-doc & MD in a relevant scientific discipline and 5 years with industry experience
Knowledge of the pathophysiology and treatment of ophthalmic disorders and related
Prior success discovering and developing successful novel medicines
Proven track record of leading research programs and establishing strong collaborations
High energy level, focus, a passion and sense of urgency for developing important new medicines for devastating diseases
现在申请