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Senior Director Process Development

Status: Archived
CompanyWuXi Biologics
LocationUS-PA-King of Prussia
Expiration2019-12-31
How to Applyhttps://careers-wuxiapptec.icims.com/jobs/5701/senior-director-process-development/job?mode=view

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.
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