Senior Director Process Development

Company:   WuXi Biologics
Location:  US
Posted:  2019-09-14

Job ID: 2019-5658 Responsibilities  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. Qualifications  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.

How to apply

 Application Link: development/job?mode=view  Please feel free to contact or +1 609-703-3769 if you have any questions.