- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Sumitomo Pharma (Sacramento, CA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- AbbVie (Irvine, CA)
- …+ Author and review CMC analytical sections of BLA and other CMC regulatory packages. Develop strategies for addressing health authority inquiries. + Provide ... supports manufacturing, process transfer/optimization/characterization/validation, analytical method transfer/optimization/validation, product characterization, regulatory submission, and continuous improvement for late-stage and commercial… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …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 ... strategy), site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director , Drug Product Manufacturing Science & Technology, you will be ... effectively with local Technical Services, site leadership, Pharmaceutical Sciences, Global Quality, Regulatory CMC , and other key functions to align on… 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 ... interactions and activity prioritization. Regularly ensures compliance with all relevant regulatory requirements. + Oversees the implementation of project plans (eg,… more
- Kelly Services (Tarzana, CA)
- …to Santa Monica, CA as needed. The contractor will report to the Associate Director of Manufacturing, NGF70. The Specialist, Manufacturing role will ensure ... or engineering discipline. * Understanding of cGMP process and knowledge of CMC regulatory framework for biologics. * Knowledge of aseptic techniques for primary… more