Senior Scientist of Formulation
上海药明康德新药开发有限公司
- 公司规模:10000人以上
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2015-06-18
- 工作地点:上海-浦东新区
- 招聘人数:若干
- 工作经验:二年以上
- 学历要求:硕士
- 语言要求:英语良好
- 职位类别:医药技术研发人员 药品生产/质量管理
职位描述
Key accountabilities:
1.Design and execute the formulation development and scale up process for solid dose and liquid dose formulation as well as other formulations as needed.
2.Perform formulation/dose preparation from lab investigation scale to clinical trial materials under cGMP accordingly.
3.Perform sample analyses including but not limited to samples for GLP toxicity dose and drug substances/drug products used for clinical trials.
4.Responsible for assigned instruments/equipments, maintaining them in proper calibration and working order according to the appropriate SOP; perform IQ/PQ/OQ calibrations as assigned.
5.Write up IQ/OQ/PQ protocols, process validation plan, formulation development report, and/or summaries/reports related to formulation and process development work.
6.Must be able to work with multiple projects and prioritize the workload to meet the pre-determined timelines.
7.Expected to accomplish their work assignments by interacting closely with fellow scientists and by developing cooperative working relationship with other personnel in the company; communication with customers when needed and instructed.
8.Good communication, open exchange of information and project teamwork will be required in order to meet job performance standards and of meeting assignments target dates at the individual job level as well as for the benefit of coworkers on project teams.
Core business/Functional skills and education:
1.Must be trained and/or have experience in formulation/dose development and process development as well as Preformulation development.
2.Must be familiar with the requirements of the cGMP/GLP regulations, ICH guidelines as well as drug development process.
3.M.S. or Ph.D. degree in pharmaceutics or other directly-related science discipline with experience or training in formulation development.
4.Must be familiar with formulation, analytical techniques, particularly dissolution apparatus, other formulation testing instruments.
5.Good communication skills, both written and verbal, and good interpersonal skills are essential job requirements.
6.Must be able to work in a team-oriented manner in order to accomplish performance objectives.
1.Design and execute the formulation development and scale up process for solid dose and liquid dose formulation as well as other formulations as needed.
2.Perform formulation/dose preparation from lab investigation scale to clinical trial materials under cGMP accordingly.
3.Perform sample analyses including but not limited to samples for GLP toxicity dose and drug substances/drug products used for clinical trials.
4.Responsible for assigned instruments/equipments, maintaining them in proper calibration and working order according to the appropriate SOP; perform IQ/PQ/OQ calibrations as assigned.
5.Write up IQ/OQ/PQ protocols, process validation plan, formulation development report, and/or summaries/reports related to formulation and process development work.
6.Must be able to work with multiple projects and prioritize the workload to meet the pre-determined timelines.
7.Expected to accomplish their work assignments by interacting closely with fellow scientists and by developing cooperative working relationship with other personnel in the company; communication with customers when needed and instructed.
8.Good communication, open exchange of information and project teamwork will be required in order to meet job performance standards and of meeting assignments target dates at the individual job level as well as for the benefit of coworkers on project teams.
Core business/Functional skills and education:
1.Must be trained and/or have experience in formulation/dose development and process development as well as Preformulation development.
2.Must be familiar with the requirements of the cGMP/GLP regulations, ICH guidelines as well as drug development process.
3.M.S. or Ph.D. degree in pharmaceutics or other directly-related science discipline with experience or training in formulation development.
4.Must be familiar with formulation, analytical techniques, particularly dissolution apparatus, other formulation testing instruments.
5.Good communication skills, both written and verbal, and good interpersonal skills are essential job requirements.
6.Must be able to work in a team-oriented manner in order to accomplish performance objectives.
公司介绍
药明康德是国际领先的开放式能力与技术平台公司,为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任,以客户为中心的宗旨,药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等,正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目,致力于将最新和***的医药和健康产品带给全球病患,实现“让天下没有难做的药,难治的病”的梦想。
联系方式
- Email:zhuyun@wuxiapptec.com
- 公司地址:江北新区华康路122号南京生物医药谷加速器四期07栋
- 电话:15738851478