公司简介
云顶新耀
所属团队
职位属性
- 招聘类型：社招
- 工作性质：全职
职位描述
- Leads API and parenteral product analytical technology transfer from global partners to local CDMOs, managing method development/validation across clinical to commercial stages. Coordinate cross-functional teams to ensure seamless CDMO project execution.
- Oversees analytical development and quality control activities at CRO/CDMOs, encompassing method development/transfer/validation, batch release testing, stability studies, troubleshooting, deviation investigations, and document review, while conducting on-site monitoring of analytical operations.
- Drives analytical troubleshooting for assigned projects through independent method development/validation at Everest R&D lab.
- Prepares and reviews regulatory submission documents (IND/NDA) and related filings as required.
- Maintains scientific expertise through literature reviews, conference attendance, and continuous field monitoring.
- Actively collaborates with other CMC Small Molecule team members to achieve organizational objectives.
任职条件
- Chemistry/Pharmaceutical Sciences degree (Ph.D. with 10+ years or M.S. with 13+ years analytical R&D experience).
- 5+ years analytical R&D experience in small molecule injectables (experience with vaccines/ biologics is a strong plus).
- Extensive hands-on experience in analytical method development/optimization/validation for both API and drug products.
- Proficient in HPLC/UPLC operation; HRMS/CAD/ELSD/NMR experience preferred.
- Thorough knowledge of ChP/USP/EP pharmacopeias and FDA/EMA/NMPA/ICH guidelines.
- Fluent technical English reading/writing (IND/NDA documentation experience).
- Strong cross-functional communication and team collaboration skills.
职位要求
- 学历要求：博士