长沙招聘

职位描述：
关键职责：
Key accountabilities:
1. Plan and execute method development and validation for drug substance.
2. Perform sample analyses including but not limited to samples for drug substance used for clinical trials and GMP drug substance to be released.
3. Execute stability program for drug substance under cGMP where applicable.
4. Characterize the primary and secondary reference standards for lab use within the company and analytical development clients.
5. Assume responsibility for assigned instruments, maintaining them in proper calibration and working order according to the appropriate SOP.
6. Write up formal analytical methods, method validation reports, stability study summary, Certificate of Analysis (CoA), method validation protocols and/or summaries/reports related to analytical research and development works.


工作范围：
Scope of the job:

1. All work will be conducted in compliance with cGMP regulations when applicable.
2. Be expected to perform the job independently with limited supervision from senior scientists, group leaders and senior management.
3. Must be customer-oriented and able to show flexibility and ability to work with multiple projects. Must be able to prioritize the workload to meet the pre-determined timelines.
4. Individuals will be expected to accomplish their work assignments by interacting closely with fellow PDS scientists and by developing cooperative working relationships with other personnel inside the company.
5. Good communication, open exchange of information and project teamwork will be required in order to meet job performance. There must be strong recognition of high performance standards and of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams.



核心工作/职业技能和教育背景：
Core business/Functional skills and education:

1. Must have experience in analytical method development and validation as well as pharmaceutical analysis according to written method/protocols.
2. Must be trained in or be familiar with the requirements of the FDA cGMP regulations, ICH guidelines as well as drug development process.
3. BD and above degree in analytical chemistry, pharmaceutical analysis or other directly-related science discipline with experience or training in pharmaceutical analysis.
4. Must be experienced with standard analytical techniques, particularly HPLC, GC. GC-MS LC-MS experience/familiarity with dissolution apparatus is desirable.
5. Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
6. Must be able to work in a team-oriented manner in order to accomplish performance objectives. 举报 分享

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。