QA/QP Operation Director CAR T
Education/Experience: Master Degree in Pharmaceutical Science, Bio- Engineering, or equivalent technical discipline is required. A minimum of 8-10 years within the biotechnological pharmaceutical industry with relevant experience related to manufacturing of Cell and Gene Products is required. A Certified Industrial Pharmacist is an advantage.
Key Capabilities, Knowledge, and Skills:
- Strong People leader skills
- Strong analytical thinking and decision-making skills.
- In-depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release and distribution processes.
- Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation related to clinical trials and cGMP regulations related to manufacturing of cell therapy products as well as knowledge of Good Tissue Practices.
- Excellent verbal and written communication skills to negotiate and communicate with external and internal customer and partners.
- Experience working with Quality systems is required.
- Experience with aseptic processing and technics is required.
- Highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.