- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or related CMC regulatory experience + Successful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA **Competencies:** ... + Advanced knowledge of regulations/guidance documents with strong technical knowledge based upon academic training and job experience. + Strong oral and writing skill. Able to write regulatory documents in highly complex technical areas. **Travel** Ability to… more
- Bristol Myers Squibb (Summit, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr. Manager / Associate Director , Global Sterility Assurance CTTO** **Location: Seattle, ... BMS with our Cell Therapy team. T he **Sr Manager/ Associate Director - Sterility Assurance, Cell therapy...contamination control. This role will also cover life cycle management and implementation of new technologies and strategies with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions to meet smooth ... established, take main responsibility for CMC lead. Provide operational coordination and management to drive strategies and activities for early and late phase drug… more