岗位职责Job Description:
1. 负责mRNA/LNP-mRNA工艺开发、中试工艺平台的搭建，通过开发和实施解决方案，克服低效和障碍，加速团队前进的能力。Responsible for establishing mRNA process development & pilot process platform. Accelerate the ability of teams to move forward by developing and implementing solutions that overcome organizational or scientific inefficiencies and hindrances
2. 领导mRNA工艺开发团队，推进mRNA候选组合的开发、工艺表征和技术转移。Lead mRNA process development teams to advance development, process characterization and technology transfer of our mRNA portfolio candidates.
3. 编写和审核sop、政策和批量生产/测试记录，以确保符合法规/cGMP操作。Authors and reviews SOPs, policies, and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
4. 负责GMP车间的管理、生产指导及相关文件体系建设。Responsible for GMP management, production guidance & related document system construction.
5. 参与客户来访，电话会议，与客户讨论工艺开发方案，提供工艺及分析方法开发、转移、验证和样品检测方案；Participate in customer visits and teleconferences, discuss process development strategy with customers, provide protocols of manufacture process, method development, tech transfer, validation and sample testing, etc.；
6. 洞察mRNA领域发展趋势和新技术应用，时刻关注行业竞争格局动态，为新产品引进和技术转让做好准备。 Lead effort to identify emerging trends and new technologies applicable to mRNA field and maintain awareness of competitive landscape. Drive operational readiness for new product introductions and technology transfers.
7. 负责员工的招聘、培训、发展、保留和绩效，以便领导和执行生产运营。Oversee the hiring, training, development, retention, and performance of staff for the leadership and execution of manufacturing operations.
8. 跟其他部门有效沟通，根据项目的需求合理安排人员和工作计划，以确保项目进度；
Communicate with other departments effectively, make plan for team member and work process according to project requirements to ensure project progress；
9. 支持集团及凯莱英生物交办的其他相关任务。
Support other related tasks assigned by the group and AsymBio.

任职要求Job requirement:
1. 分子生物学、生物化学、细胞生物学、生物工程等相关专业硕士及以上学历。Master degree or above in molecular biology, biochemistry, cell biology, bioengineering or related disciplines;
2. 至少5年制药/生物技术行业工作经验, 具备mRNA相关经验。 At least 5 years of experience in the pharmaceutical/biotech industry，experience working with mRNA preferred.
3. 具有在制药或生物技术公司工艺开发或技术开发小组或职能的领导经验，具有指导和培 养技术人员的能力。Prior leadership experience Process Development, or Technical Development groups or function for a pharmaceutical or biotechnology company. Demonstrated ability to mentor and develop a technical staff.
4. 对药品开发各个阶段的质量体系、cGMP和行业标准有广泛的了解。Extensive knowledge of quality systems, cGMP, and industry standards at all phases of drug development.
5. 了解CMC战略，ICH指南和监管支持任务(IND, BLA, RTQ和PAI)。 Knowledge in CMC strategy, ICH guidelines, and regulatory support tasks (IND, BLA, RTQ, and PAI).