岗位职责：
基于候选人经验，负责XDC QC 无锡基地大分子产品检测团队（或部分功能组） 的日常运营，管理范围包括药典检测，过程检测， 理化检测， 生化检测以及活性检测等部分或者全部检测团队。 职责包括但不限于
1.负责大分子产品检测团队日常运营，保证团队高效，高质，低成本运营。
2.负责QC承接项目按时、高质量交付，以保证收入目标达成和客户满意度
3.保证日常运行的GMP合规，数据可靠和EHS合规
4.对运营中出现的调查提供帮助和指导，并协助制定相关CAPA
5.监督 QC 实验室工作人员的培训、评价和管理。指导、发展和支持他们充分发挥潜力。
6.负责监管机构和客户的良好生产规范审计。回复稽查报告并创建CAPA。

Job Responsibilities:
Based on candidate experience, management includes some or all testing teams for compendial testing, in-process testing, physicochemical testing, biochemical testing, and activity testing. The responsibility includes but not limited to:
1. Manage the routine operation of testing team to ensure the business delivery at the right quality, cost and speed.
2. Responsible for QC undertaking on-time, high-quality delivery of project to ensure revenue target achievement and customer satisfaction
3. Ensure all the activities in QC team performed with compliance of cGMP, data integrity and EHS requirement.
4. Provide support and technical directions for any technical/experiment work required during investigation and definition of corrective and preventive actions.
5. Oversight of the training, evaluation and management of the staff in QC lab. Coaching, developing and supporting them in reaching their full potential.
6. Responsible for the GMP audit from regulatory authorities and clients. Reply to audit reports and create CAPAs.


任职要求：
1.硕士及以上学历，药学、化学、生物化学、分析化学等相关专业。
2.具有10年以上生物技术或生物制药相关工作经验，其中5年团队管理经验。
3.对药物开发过程的整体观点有很好的理解。
4.对cGMP合规的原则和管理有深入的了解，有强烈的质量意识。
5.全面了解FDA、EMA、NMPA、ICH、世界卫生组织技术指南和欧洲药典、中国药典。
6.具备IND/IMPD、NDA和ANDA申请的全面知识。
7.英语听说读写流利。

Job Requirements:
1. Master degree or above, major in pharmacy, chemistry, biochemistry, analytical chemistry or other related discipline.
2. Have 10+ years relevant working experiences in biotech or biopharma, including 5 years team management experience.
3. Have good understanding of the overall view of drug development process.
4. Have thorough understanding of the principles and management of cGMP compliance, and strong quality minds.
5. Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, Ch.P pharmacopoeia.
6. Comprehensive knowledge in IND/IMPD, NDA and ANDA filing。
7. Fluent in written and spoken English language skills.