长沙招聘

Key accountabilities:
1.Plan and execute preformulation studies for drug substances including but not limited to solubility studies, stability studies and HPLC method development
2.Be familiar with early phase drug development and have working knowledge of preclinical candidate characterization to support drug development program
3.Plan and execute method development and validation for drug substances and products.
4.Draft protocols for preformulation study and analytical development.
5.Draft the IQ/OQ/PQ protocols of instruments.
6.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.
7.Write up formal reports of preformulation study, analytical method development and validation, stability study and COA.
8.Function as project manager role in preformulation development projects under the instruction of superior leader.
9.Quick adaptability to new technical domain and outstanding communication skills in English.

Core business/Functional skills and education:
1.M.S. or Ph.D. degree in pharmaceutical science, pharmaceutical analysis, physical chemistry/ physical pharmacy or other directly-related science discipline with experience or training in formulation development.
2.Must be familiar with the requirements of the cGMP/GLP regulations, ICH guidelines as well as drug development process.
3.Must be trained and/or have experience in formulation/dose development and process development as well as Preformulation 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.


Key accountabilities: 1. Lead the efforts for preformulation studies and analytical development within the PDS department; function as project manager role in preformulation projects; 2. Plan, Coordinate, and oversee the work activities of scientific staff within the assigned group 3. Review planning and execution of preformulation studies for drug substances including but not limited to determination of physicochemical properties and measurement of powder properties polymorph screening and salt form selection. 4. Review and amend work protocols, progress reports and final reports for preformulation projects handled for review and approval by customers. 5. Review planning and execution of support for formulations for toxicity studies by performing sample analyses ( assay, related substances, particle size determination, form change etc) 6. Work closely with preformulation group leader to perform daily management of the preformulation and analytical labs; conduct the group training in technology and compliance as needed. Qualification: 1. Ph.D. degree in pharmaceutical science, pharmaceutical analysis, physical chemistry/ physical pharmacy or other directly-related science discipline. 2. 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, DSC, TGA is desirable. 3. Must have experience in preformulation area or analytical development as well as pharmaceutical analysis according to written method/protocols. 4. Must be trained in or be familiar with the requirements of the FDA cGMP/GLP regulations, ICH guidelines as well as drug development process. 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.

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。