Responsibilities
1. The position is responsible for process development and optimization, analytical development, process and product characterization.
2. Develop, review, and approve tech transfer document, development report, risk assessments, comparability strategies, PC/PV strategy, PPQ protocols and regulatory filings.
3. Lead the product technology transfer including the transfer from PD to clinical manufacturing plant, and support tech transfer to commercial plant.
4. Collaborate with other functional areas and clients to ensure timely completion of PD activities to meet project timeline.
Qualifications
1. PhD in Chemistry, Bioengineering, Immunology, Pharmaceutical Sciences or related fields.
2. Over 10 years of experience in pharmaceutical industry.
3. Strong experience with process development and analytical development in pharmaceutical development.
4. In depth knowledge of immune-oncology and cell based therapy.
5. Thorough knowledge of pharmaceutical industry regulations.
6. Proven record of supervisory and project management experience.
7. Strong analytical skills in sorting information, formatting directions and problem solving. Logical thinker and quick learner.
8. Good communication skills and positive interpersonal skills.
9. Good English (written and spoken) and Chinese.