- BeOne Medicines (San Mateo, CA)
- …implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global ... product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for...lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and investigator brochures,… more
- AbbVie (North Chicago, IL)
- …interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval of sections of ... with CMC Regulatory and Process R&D. + Partner with CMC Regulatory to assist CMC project teams in identifying submission-related risks and develop… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director - CMC BioDPDM **Location** : Framingham, MA As Associate Director within CMC BioDPDM, you'll have the opportunity ... could turn the impossible into possible for millions. The Associate Director role is a key leadership...Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing. You will… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... (HA) information requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as… more
- AbbVie (North Chicago, IL)
- …and automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, ... ongoing basis . Provide guidance, technical advice, planning, and project management within SM CMC and with...advice, planning, and project management within SM CMC and with outside functions, consultants, and vendors. Support… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …academic community. **Description** The Goizueta Business School is in search of an Associate Director - Graduate Student Advising and Programming to join the ... who is passionate about supporting early-career college and international students. The Associate Director will be responsible for designing, developing, and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for ... site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing applications for global… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Associate Director , Genomic Medicine Purification Process Development **Location:** Waltham, MA Work Model: M-F onsite **About the Job** Are you ... our teams accelerate progress. The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment...Group located in Waltham, MA in the role of Associate Director . The GMU PPD group operates… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) - Digital Health **Location:** Cambridge, MA/ Morristown, NJ **About the Job** GRA Device Lead ( Associate ... of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The...GRA Device Lead for DHTs and SaMDs on assigned project teams (early phase, late stage and marketed products)… more
- University of Southern California (Los Angeles, CA)
- …cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all ... including manufacturing and process development activities, in order to ensure that project deliverables meet schedule, cost, scope, quality, and safety and ensuring… more