南京招聘

Key accountabilities:
1.Perform analytical and analytical development studies within the ARD department; function as analytical scientist role in analytical projects;
2.Plan and execute analytical stability studies for drug substances and drug products; perform sample analyses including but not limited to samples for GMP toxicity dose and drug substances/drug products used for clinical trials;
3.Carry out method validation protocol and coordinate the execution of the protocol.
4.Design and review stability program protocols for both drug substances and drug products under cGMP where applicable; coordinate the execution of the protocols.
5.Carry out and/or review the formal analytical results, method validation reports, stability study report, Certificate of Analysis (CoA), summaries/reports related to analytical research and development works, and/or IQ/OQ/PQ protocols.
6.Be expected to work closely with group/project leader to meet project timelines, departmental goal, and customer requests.
7.Perform daily routine analytical studies of the analytical lab; conduct the group training in technology and compliance as needed.


Core business/Functional skills and education:
1.Must have experience in analytical research 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/GLP regulations, ICH guidelines as well as drug development process.
3.BS, MS or Ph.D. 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 and preformulation study instruments such as XPRD, laser particle size distribution is desirable.
5.Must be able to work in a team-oriented manner in order to accomplish performance objectives.
6.Must have supervisory experience in a pharmaceutical R&D environment in both project and people management.
7.Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
8.Strong technical expertise in analytical chemistry and pharmaceutical analysis.


Scope of the job:
1.All work will be conducted in compliance with cGMP/GLP regulations when applicable.
2.Be expected to perform the assigned job functions independently with limited supervision from upper management.
3.Must be able to work with multiple projects and prioritize the workload to meet the pre-determined timelines.
4.Individuals will be expected to accomplish their work assignments by interacting closely with fellow scientists and by developing cooperative working relationships with other personnel inside the company; communicated with customers when needed and instructed.
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

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。