Analytical Director

A listed biotech is seeking a Analytical Head candidate!

Your new company

Our client is a listed biotech focused on cutting-edge drug discovery.

Your new role

1. 负责创新药API和制剂的分析方法开发、验证和转移,以及相关质量研究;

2. 在日常业务的各个方面指导和管理分析团队,包括员工招聘和发展,日常运营工作,GMP 合规,预算和费用跟踪。

3. 与不同职能部门的同事协调,准备新项目的技术方案,制定开发工作的成本和时间预算;

4. 熟悉新药开发法规指南指导分析研发工作,负责撰写审核研发产品的分析相关注册申报资料;

What you'll need to succeed

1. 药学、分析化学或药物分析等相关专业博士学历,具有药物分析、质量研究等药物研发十年以上工作经验;

2. 有制剂(必须)和API质量研究经验,熟悉CDE和FDA政策以及ICH和WHO指南,有完整的NDA经验优先;

3. 熟悉新药注册管理程序,对数据完整性有深入了解,能协助建立合规的质量体系;

4. 有较强的英语写作能力;

5. 良好的责任心及团队协作精神,较强的沟通能力和领导力,抗压能力强。

What you'll get in return

Competitive salary with an upcoming company platform to expand your skills & knowledge.

What you need to do now


If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.

Summary

Job Type
Permanent
Industry
Pharmaceuticals
Location
Shanghai
Specialism
Life Sciences
Ref:
1253888
Closing date
15 Mar 2025

Talk to a consultant

Talk to Jack Guo, the specialist consultant managing this position, located in Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)

Telephone: +8613512179068

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