- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within ... based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a ... manufacturing plans at the site which are aligned with cross-functional CMC strategic discussions. Manage timelines, deliverables, and coordinate the input of… more
- WuXi AppTec (Philadelphia, PA)
- …product projects, ensuring timely and high-quality delivery **Responsibilities** * Provide analytical CMC -related support for new working order signing at ... qualification protocols and reports etc. * Author and support the analytical CMC section for IND/IND amendment/BLA application documents for the target country,… more
- Bristol Myers Squibb (Princeton, NJ)
- …(including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director , Biologics will serve as the ... between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS- CMC Associate Director , Biologics will assess Manufacturing Change… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , Cell Therapy Decisional Analytics - 2406185128W **Description** Johnson & Johnson is recruiting an Associate Director , Cell Therapy ... We are looking for an energetic and highly motivated Associate Director candidate with demonstrated expertise in...the development and use of a variety of rapid analytical approaches to support cell therapy and lentiviral vector… more
