- Support senior leadership to build up global DS technical capability;
- Support senior leadership to align global DS technical capability across the Company;
- Lead and provide overall coordination to execute late stage process development, process characterization, technology transfer, PPQ readiness;
- Lead and provide oversight for DS commercial launch – facility start up, PPQ, BLA, pre-license manufacturing site inspection;
- Serve as technical point-of-contact to Client on CMC issues;
- Provide guidance and mentorship to DS technical staff;
- Lead DS related assignments as directed by management – development, transfer, commercialization.
- PhD in engineering, biology, chemistry, or related field.
- 15+ years relevant work experience.
- Late stage biologic product/process development and commercialization expertise.
- SME of global standards in DS CMC, GMP, GDP, regulatory applications (IND to BLA).
- Effective management of projects and staff, cross-departmental collaborations are expected.
- Outstanding communication and language skills.