药物流程开发工程师

工作职责：
1、负责"肠道菌群移植"(FECAL MICROBIOTATRANSPLANTATION，FMT)项目方案的执行，落实胶囊技术的制备及工艺优化，包括供体筛选、微生物分离、胶囊制备、质量检测等流程；
2、负责研发项目的工作计划和总结，实时追踪项目的最新进展，确保项目按计划顺利进行；
3、负责研发项目的资料整理、归纳、汇总和审核；
4、负责按照注册申报法规要求进行制剂流程部分申报资料的撰写；
5、学习并完善关键技术和设备，负责产品质量项目的检测和评价。

任职要求：
1、学历要求：博士应届生，或有3年以上工作经验的硕士；
2、专业要求：微生物学/药物制剂/生物医药工程等相关专业；
3、良好的实验操作能力，熟悉使用常规制剂研发仪器及生产设备、能独立开展工作，有接触 或参与过FMT或者口服胶囊制剂的项目经验优先考虑；
4、具有熟练的英文文献阅读能力，具备较强的中英文写作能力；
5、诚实守信，具有良好的沟通、表达及团队协作能力。

Company introduction:

As the first AI-base******** drug development company in Ch********Xbiome Co., Ltd. is dedicate******** gut microbiome using AItechn******** an******** to the gut health of 1.3 billion people withprecise an******** management. Different from the traditional''Cell-Animal-Human'' paradigm of drug ******** Xbiome's approachinnovatively combines AI technology, bioinformatics analysis an********microbiome techniques into a unique drug development platform, whichsubstantially speeds up new drug ******** an******** the rate of drugsuccess. Backe******** world-class venture capitals in China an********,currently Xbiome works closely with FDA to bring its innovative drugproduct to clinical trial phase.

Job Title:

Pharmaceutical Process Development Engineer
Base******** Shenzhen, China.

Job Description:

Essential duties an****************
1. Design an******** the production process of the Fecal MicrobiotaTransplantation (FMT) capsule, including donor screen******** microbialenr******** capsule pro******** QA/******** an******** processes;
2. Responsible for supervising junior members in the project team;
3. Improve current procedure an********, an******** critical technicalproblems;
4. Responsible for setting up product quality standards an********/QCprocess;
5. Help file regulatory document relate******** process development tosupport regulatory filing;
6. Help planning an******** FMT capsules production in GMP factory.

Requiremen********

1. Doctoral degree or master degree with 3 years working experience;
2. Majore******** a relevant discipline such asMicrobiology/Pharmaceutical Science/Bioengineering /Formulation;
3. Goo******** skills. Experience with FMT or capsule production isstrongly preferred;
4. Proficient in English. Able to rea******** publications an********critically. Goo******** skills in both Chinese an********;
5. Have goo******** skills an******** able to work in a cross-functionalteam.