Analytical Principal Scientist / Lead 高级研究员-分析科学

工作职责：

1. 领导初级科学家开发基于液相色谱/电泳技术的蛋白质治疗药物早期及晚期开发分析方法，包括方法开发/评估、验证、故障排除，并在工作流程、新分析技术或业务机会方面进行创新。
2. 作为分析职能负责人，支持CMC项目，包括时间线管理；提供跨职能支持与反馈以促进工艺开发；起草IND和BLA等监管申报资料中的相关CMC章节。
3. 能够就想法、项目目标和结果，向跨职能团队成员和/或客户进行有效沟通。
4. 具备强大的CMC和监管知识者优先。

任职要求：

1. 需拥有分析化学、生物化学或相关专业硕士或博士学位，并具备1-5年相关经验，能证明其在分析方法开发和科学成就方面的专长。
2. 具备出色的中英文口头和书面沟通能力。 拥有海外留学背景或全英文授课的学历背景者优先
3. 具有丰富的HPLC/CE/MS技术实践操作经验。具备CMC领域HPLC/CE/MS方法开发与验证的工业界经验者优先。
4. 具备蛋白质治疗药物的生物化学和物理化学表征经验。
5. 拥有良好的科技写作能力，并有在科学技术期刊上发表同行评审论文的记录。
6. 具备与监管机构（如FDA、EMA、CDS等）沟通的经验者优先。

Work Scope:

1. Lead junior scientists to develop liquid chromatography/electrophoresis-based methods for protein therapeutics development in early and late stages, including method development/assessment, qualification, troubleshooting and innovation on workflow, new analytical techniques, or business opportunities.
2. Work as analytical function lead to support CMC projects, including timeline management; cross-functional support and feedback to facilitate process development; draft relevant CMC sections for regulatory submissions including INDs and BLAs.
3. The candidate should be an effective communicator of ideas, project goals and results to cross-functional team members and/or clients.
4. Strong knowledge in CMC and regulatory is preferred.

Qualifications:

1. Requires a master/Ph.D. in analytical chemistry, biochemistry and 1-5 years of relevant experience that demonstrates an expertise in assay development and scientific accomplishments.
2. Excellent verbal and written communication skills in both Chinese and English. Candidates with overseas study experience or a full English‑taught academic background will be given preference.
3. Extensive hands-on experience in HPLC/CE/MS technologies. Industrial experience in development and validation of HPLC/CE/MS methods for CMC applications is preferred.
4. Experience with biochemical and physiochemical characterization of protein therapeutics.
5. Records of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journals.
6. Experience interacting with authorities (FDA, EMA, CDS, etc) is preferred.