• 招聘类型：社招
• 工作性质：全职

职位描述

• Lead and direct analytical method development and corresponding method validation.
• Provide constructive guidance in pharmaceutical analytical work to establish quality study and quality specification for raw materials and finished dosage forms.
• Review and update stability study data records and related CMC documents to ensure data integrity to fulfill regulatory requirements.
• Coordinate with synthesis and formulation divisions to make comprehensive impurities analysis plans.
• Provide decisive leadership and operational expertise to ensure successful tech transfer of analytical method to industrial QC/QA divisions.
• Deeply understand ICH, USP, EP, ChP etc., standards and regulatory guidance to conduct analytical research and development and set up SOP standard.
• Ensure all R&D activities follow ICH, USP, EP, ChP etc., standards and regulatory guidance to support IND/NDA filings and mitigate risks of deficiency.
• Work cross-functionally within the organization to help shape and meet product life-cycle timelines and support synthesis and formulation divisions.
• Lead and direct API physicochemical properties analysis and pre-formulation research and development including procurement of necessary instruments.

任职条件

• PhD degree of Analytical Chemistry with 10+ years relevant work experience in industry. US or European Pharma experience preferred.
• Hands-on experience on analytical team build and strong problem-solving skills.
• Solid working knowledge of ICH, USP, EP, ChP etc., regulatory guidelines.
• Experienced in CMC document preparation for IND and NDA.
• The candidate should be a very effective communicator, interacting with key stakeholders, regulators and other technical lines and matrix teams.
• Strong written and communication skills and an ability to work effectively with a diverse team of co-workers in a dynamic environment.

职位要求

• 学历要求：博士
• 工作经验：10年以上
• 外语要求：不需要

公司福利

• 五险一金 
• 晋升空间 
• 法定节假日