- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, International Conference on Harmonization (ICH), ... company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and determines filing strategies, provides expertise as regulatory CMC… more
- ThermoFisher Scientific (New Brunswick, NJ)
- …all while maintaining full-time benefits. **Key responsibilities:** Versatile, biologics development GxP laboratory seeks a hard-working, results-focused Research ... & Development scientist with experience in protein analysis to bring an outstanding R&D Biologics portfolio to market. + Independently perform biologics … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …topics. **Responsibilities** - Supports CMC regulatory compliance activities for portfolio biologics to meet US, International Conference on Harmonization (ICH), and ... company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and determines filing strategies, provides expertise as regulatory CMC… more
- Bristol Myers Squibb (Princeton, NJ)
- …analysis responsibilities such as protein binding, AMS, LC-MS technology lead on biologics , biomarker, etc. + Enhance the scientific credibility of BMS through ... contributions to the scientific literature (publications/presentations), through extramural activities and scientifically related interactions with academic and health authorities. + May require travels to CROs for monitoring visits. **Basic Qualifications** +… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …as equivalent experience. **Key Skills and Experience** + Expert in Biologics /sterile/liquid drug product packaging systems design and/or manufacture. + Experience ... with drug product parenteral visual inspection techniques, standards, and forensics with respect to primary container defects preferred. + Deep scientific understanding of the materials science and technology behind the manufacture and design of primary… more
- Novo Nordisk (Princeton, NJ)
- …personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist /Sr. Manager Regulatory Affairs. Develop and maintain positive rapport ... MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics , Devices) to government agencies in support of research and marketed… more
- Sanofi Group (Bridgewater, NJ)
- …analyses from the development program dupilumab for additional publications. + Supervise physician/ scientist in charge of the execution of the GMA LCM and data ... Global experience highly advantageous. + Experience in Medical Affairs with Biologics (Dermatology, Rheumatology, Gastro others.) highly advantageous. + Able to work… more
