长沙招聘

Key accountabilities:
1. Plan and execute method development and validation for drug substances and products.
2. Perform sample analyses including but not limited to samples for drug substances/drug products used for clinical trials;
3. Execute stability program for both drug substances and drug products under cGMP where applicable.
4. Analyze heavy metals/counter ions in drug substance/product. Do compound structure confirmation study as requested. All work will be conducted in compliance with cGMP/GLP regulations when applicable.
5. Assume responsibility for assigned instruments, maintaining them in proper calibration and working order according to the appropriate SOP; perform IQ/PQ/OQ calibrations as assigned.
6. Write up formal analytical methods, method validation reports, stability study summary, Certificate of Analysis (CoA), IQ/OQ/PQ protocols, method validation protocols and/or summaries/reports related to analytical research and development works.

Requirements：
1. BS degree with 4 years above working experience, or MS degree with 2 years above experience in analytical chemistry, pharmaceutical analysis or other directly-related science discipline with experience or training in pharmaceutical analysis.
2. Must be experienced with ion/heavy metal detection techniques, particularly IC, ICP-OES, ICP-MS; Experience in structure confirmation study instruments such as NMR, IR, UV is a plus. Experience/familiarity with pre-formulation study instruments such as XPRD, DSC, TGA, laser particle size distribution is desirable.
3. Be expected to perform the job independently with limited supervision from senior scientists, group leaders and senior management.
4. Strong English communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
5. Must have experience in analytical method development and validation as well as pharmaceutical analysis according to written method/protocols.
6. Must be trained in or be familiar with the requirements of the FDA cGMP/GLP regulations, ICH guidelines as well as drug development process.
7. Must be able to work in a team-oriented manner in order to accomplish performance objectives.
8. 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.

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。