药代动力学试验药物制剂主管
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:2015-04-15
- 工作地点:上海-浦东新区
- 招聘人数:若干
- 工作经验:5-7年
- 学历要求:硕士
- 语言要求:英语良好
- 职位月薪:面议
- 职位类别:医药技术研发管理人员
职位描述
KEY ACCOUNTIBILITIES:
1. 1. Design study protocols/approaches of vehicle selection for solution and suspension dosing for preclinical in-vivo PK, PK/PD and efficacy studies in discovery.
2. Lead and perform physicochemical property studies such as Solubility, Ionization Constant (pKa), Lipophilicity, Surface Acitivity and Stability studies to evaluate the drug like properties and develop-ability, etc.
3. Review technical reports/documents generated by formulation group.
4. Serve as a resident expert in Preformulation area to optimize the capability of formulation group to create innovative and efficient solutions and in-depth scientific knowledge and experience.
5. Interface with project teams to provide formulation expertise and communicate results of formulation experiments
6. Responsible for drafting, reviewing, and implementing of analytical related SOPs or guidelines, as well as maintaining & troubleshooting of all formulation related analytical instruments.
7. Supervise 7~8 scientists. Coach junior scientists in implementing innovative solutions for assigned Preformulation activities; be responsible for performance plan & review, and career development for direct reports.
8. 设计选择溶媒的实验方案和方法,以用于临床前体内药物代谢以及研发阶段药物代谢和药效研究所需溶剂溶液。
9. 领导和执行物理化学实验,例如有关溶解性、电离常数、亲油性、表面活性或稳定性的实验以评测药物性能和研发状况等。
10. 审查制剂组制作的报告和相关文件等。
11. 具备预制剂方面非常丰富的专业知识和经验,提高制剂组有效和创新的提出实验解决方案的能力,使制剂组具备扎实深入的科研知识和积累经验。
12. 与项目组配合,提供制剂的专业知识,并交流实验结果。
13. 起草、审阅和实施制剂分析相关的安全合规和指南,维护仪器和解决配剂相关问题。
14. 监管7~8个实验人员。指导初级研究人员制剂的方法,负责实施方案和实验总结,实验报告的规划。
REQUIREMENTS:
1. Ph.D. degree in pharmaceutical analysis/pharmaceutical science (or closely related field) or Master degree with at least 5 years’ working experience in pharmaceutical (or chemical) industry.
2. Solid knowledge on preformulation theories, and hands-on experience in operating, calibrating, maintaining and troubleshooting of a wide range of instruments (HPLC, LC/MS/MS, DSC, PSD, TGA, PLM, DVS, IR, XRPD, etc).
3. Knowledge on formulation theories and technologies would be a plus.
4. Must be able to manage project; must possess strong problem solving and troubleshooting abilities. Must be proactive and self-motivated.
5. Must be a good team player with good interpersonal communication skills.
6. Fluent in both written and spoken English; can deliver good presentations in English and Chinese.
7. 药物分析、药学或相关领域博士;或在药物领域有5年以上工作经验的硕士。
8. 有扎实的制剂理论基础,具有在不同的仪器领域(HPLC, LC/MS/MS, DSC, PSD, TGA, PLM, DVS, IR, XRPD, etc)10. 操作、校正、维护和解决问题的经验。
9. 优先考虑有制剂理论和技术的应聘者。
10. 管理项目,有很强的解决问题和排除故障的能力。积极主动,有上进心。
11. 具有良好的沟通能力和团队合作精神。
12. 流利的英语口语和写作,能以中英文做实验展示。
1. 1. Design study protocols/approaches of vehicle selection for solution and suspension dosing for preclinical in-vivo PK, PK/PD and efficacy studies in discovery.
2. Lead and perform physicochemical property studies such as Solubility, Ionization Constant (pKa), Lipophilicity, Surface Acitivity and Stability studies to evaluate the drug like properties and develop-ability, etc.
3. Review technical reports/documents generated by formulation group.
4. Serve as a resident expert in Preformulation area to optimize the capability of formulation group to create innovative and efficient solutions and in-depth scientific knowledge and experience.
5. Interface with project teams to provide formulation expertise and communicate results of formulation experiments
6. Responsible for drafting, reviewing, and implementing of analytical related SOPs or guidelines, as well as maintaining & troubleshooting of all formulation related analytical instruments.
7. Supervise 7~8 scientists. Coach junior scientists in implementing innovative solutions for assigned Preformulation activities; be responsible for performance plan & review, and career development for direct reports.
8. 设计选择溶媒的实验方案和方法,以用于临床前体内药物代谢以及研发阶段药物代谢和药效研究所需溶剂溶液。
9. 领导和执行物理化学实验,例如有关溶解性、电离常数、亲油性、表面活性或稳定性的实验以评测药物性能和研发状况等。
10. 审查制剂组制作的报告和相关文件等。
11. 具备预制剂方面非常丰富的专业知识和经验,提高制剂组有效和创新的提出实验解决方案的能力,使制剂组具备扎实深入的科研知识和积累经验。
12. 与项目组配合,提供制剂的专业知识,并交流实验结果。
13. 起草、审阅和实施制剂分析相关的安全合规和指南,维护仪器和解决配剂相关问题。
14. 监管7~8个实验人员。指导初级研究人员制剂的方法,负责实施方案和实验总结,实验报告的规划。
REQUIREMENTS:
1. Ph.D. degree in pharmaceutical analysis/pharmaceutical science (or closely related field) or Master degree with at least 5 years’ working experience in pharmaceutical (or chemical) industry.
2. Solid knowledge on preformulation theories, and hands-on experience in operating, calibrating, maintaining and troubleshooting of a wide range of instruments (HPLC, LC/MS/MS, DSC, PSD, TGA, PLM, DVS, IR, XRPD, etc).
3. Knowledge on formulation theories and technologies would be a plus.
4. Must be able to manage project; must possess strong problem solving and troubleshooting abilities. Must be proactive and self-motivated.
5. Must be a good team player with good interpersonal communication skills.
6. Fluent in both written and spoken English; can deliver good presentations in English and Chinese.
7. 药物分析、药学或相关领域博士;或在药物领域有5年以上工作经验的硕士。
8. 有扎实的制剂理论基础,具有在不同的仪器领域(HPLC, LC/MS/MS, DSC, PSD, TGA, PLM, DVS, IR, XRPD, etc)10. 操作、校正、维护和解决问题的经验。
9. 优先考虑有制剂理论和技术的应聘者。
10. 管理项目,有很强的解决问题和排除故障的能力。积极主动,有上进心。
11. 具有良好的沟通能力和团队合作精神。
12. 流利的英语口语和写作,能以中英文做实验展示。
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