- Otsuka America Pharmaceutical Inc. (Salem, OR)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: Associate Director -Process Engineer SM API Process Sci** **Location: Cambridge, MA ... (Hybrid)** **About the role:** As an Associate Director -Process Engineer SM API Process Sci,...o Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision… more
- BeOne Medicines (Emeryville, CA)
- …to lead our Research, Supply Production and Financial Analytics Initiatives. The Associate Director Research, Supply Production and Financial Analytics, Data ... tools for early discovery and translational research, supply readiness, CMC , cross-functional resource utilization, vendor performance and cost scenario modeling… more
- US Tech Solutions (Holly Springs, NC)
- …new Drug Substance production facility. Responsible for also being able to enable CMC Regulatory file drafting and support, commissioning and qualification of ... Scale-up, Clinical & Commercial Manufacturing Support, Process Performance Qualification (PPQ), CMC Regulatory file drafting and support, commissioning and… more
- Sanofi Group (Framingham, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) **Location** : Morristown, NJ/ Cambridge, MA/ Framingham, MA **About the Job** Are you ready to shape the ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** GRA Device Lead ( Associate Director ) **Location:** Cambridge, MA/ Morristown, NJ **About the Job** Are you ready to shape the future of medicine? ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- J&J Family of Companies (Raritan, NJ)
- …as a single submission. **We are searching for the best talent for an Associate Director , Submission Program Management Lead to be located in Raritan, NJ; ... SPML will be a key partner to the Global Regulatory Leader (GRL), Compound Development Team Leader (CDTL) and...near critical path (eg, LPO, DBL, TLR/TLG, CSR, Non-Clinical, CMC ) into ISP. + Maintaining and communicating execution level… more
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- ... cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all… more
- Merck (Rahway, NJ)
- **Job Description** The Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral ... prior experience developing and commercializing new products on cross-functional teams. The Associate Director will be accountable for the definition and… more
- Takeda Pharmaceuticals (Boston, MA)
- …DP/PKG** **Location: Cambridge, MA** **About the role:** As a Process Scientist ( Associate Director ) - Global Manufacturing Science GMSci Drug Product (DP), ... and the life cycle management of existing products. You will lead regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls (… more