Let's work together to make CFS the first choice of oral formulation CDMO
for new drugs worldwide.
Promotion: fast track promotion available based on performance.
Model: dual pathway for technical or managerial ladders
Rotation and Internal Transfer: provide multi-platform job rotation and transfer opportunities between different BU within CFS and Crystal Pharmatech Group.
Professional Technical Training: principles of formulation development and analytical science, introduction of advanced instruments and equipment, design of experiments (DOE) data analysis, simulation, report writing etc.
Leadership Training: general management, project management, team-building, problem solving, strategic planning, presentation skills etc.
Employees who have worked for more than 3 years with good performance can apply for advanced degrees through online or part-time learning, and the company supports 50% of the tuition.
1. Responsible for analytical method development for oral solid dosage (OSD) products, ensuring analytical methods are fully validated in accordance with SOPs, regulatory guidelines and meets specification requirements during all phases of new product development
2. Directs, plans, and oversees the analytical activities of product development, method development and validation, methodtransfer, and support OSD products process development and manufacture.
3. Design and manage stability experiments, including prototype/probe stability, IND stability, FFS study, etc.
4. Assures accurate and timely testing and reporting of all results; approves and issues technical reports which include all certification and validation data as appropriate. Presents data and summary of findings to cross-functional teams and senior management.
5. Working closely with clients to ensure project progress on track from analytical perspective.
6. Responsible for reviewing batch record of materials and product release testing
7. Responsible for the preparation of analytical technical documents for technology transfer executions and solving potential analytical problems during project transfer to the manufactory in a timely manner
8. Provides data for the preparation of CMC section of regulatory submissions, works closely with cross-functional teams to author/review CMC content and responses to regulatory authorities where applicable. (e.g. P5-P8)
9. Responsible for OOX investigation, root cause analysis and CAPA
10. Participate in the drafting, reviewing and update of relevant SOPs
11. Responsible for managing and developing direct and indirect reports and actively fostering employee engagement and enablement of the team.
1. Ph.D. degree, graduate in analytical chemistry, organic chemistry, or related technical field, fluent in oral English
2. More than 5 years of related hands-on experience in well-known pharmaceutical companies, and experience in CDMO industry is preferred
3. Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and regulatory guidance (ICH, FDA, EMA, NMPA, etc.) documents as they relate to manufacture and quality testing of pharmaceutical products
4. Familiar with policies and regulations of new drug development, demonstrated solid management experience with stability programs in all stages of drug product development and manufacturing.
5. Excellent analytical development capabilities, including analytical method development, identification of degradates and unknown impurity structures by LC-MS and NMR, etc.
6. Understand cutting-edge technologies such as Biorelevant dissolution, amorphous solid dispersions technology.
7. Scientific driving, open and optimistic, solid, and resilient, good at communication and coordination, and have excellent teamwork spirit
8. Excellent learning ability, agile to think and analyze problems thoroughly
9. Excellent execution ability, fast andaccurate.