職位描述
Responsible for extractable &leachable project, working to design protocol, execute experiment plan, interpret data and generate scientific reports, supporting chemistry lab daily maintenance.
1. Extractable & Leachable project
- Design protocol, execute experiment plan, interpret data, and generate scientific reports. Design and conduct analysis on extractable for raw materials and leachable in stability of drug samples and drug products using ICP-MS, UPLC/MS, GC/MS/FID, and various analytical methods.
- Test method development, verification and validation, method translation. Develop proper methods for leachable target in drug products. Unknown peak identification and quantitation.
- Apply existing methods and develop new methods to investigate compatibility between drugs and containers / packaging materials, contributing to regulatory submissions, analytical services for customers and complaints handling.
- Keep close communication with global R&D labs to ensure the test method synchronization.
2. Others
- Laboratory routine instruments maintenance, operation, documentation, safety and sample/reagent management to meet the quality and regulatory compliance.
- Work with other functions such as QA, EHS, Procurement and Supply Chain.
- Work with 3rd party labs for sample analysis when needed
SKILLS AND ABILITIES
- At least Bachelor's degree in Pharmaceutics, Pharmacy, Analytical Chemistry, Chemical Engineering or related discipline with at least 3 years of relevant experience.
- Knowledge and extensive hands-on experience with method development for LC/MS, GC/MS, ICP-MS.
- Must have extensive experience with method validation and transfers for analytical methods according to current regulatory and pharmacopeia guidelines.
- Knowledge of drug packaging materials of glass, rubber and plastics.
- Be familiar with CHP, YBB, GB, USP, EP, ICH etc.
· At least three years of experience in chemical laboratory under ISO17025/GLP/GMP quality system.
· Ability to work independently and experience in a team on multiple projects
· Excellent interpersonal and communication skills
· Excellent communication (oral and written) and interpersonal skills in order to interface with global R&D groups, global manufacturing plants and regulatory teams.
Be careful and conscientious; be initiative, independent, good communication and team collaboration.
