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- The companys second clinical-stage asset, currently in Phase 1, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
- Rezolute is seeking an experienced chemist, chemical engineer, or pharmaceutical scientist to lead the CMC development programs for our portfolio of small molecule drug candidates.
- They will be responsible for all aspects of CMC strategy, process - analytical development and cGMP manufacturing.
- Providing technical and scientific leadership as subject matter expert (SME) relating to technology transfers, manufacturing processes, complex deviations, technical troubleshooting, CAPA design and implementation, process monitoring, change control and process development and optimization
- Acts as person-in-plant and technical advisor during tech transfer, start-up, validation studies and clinical manufacturing
- Bachelors or Masters degree in Chemistry/Chemical Engineering, Pharmaceutical Science or related discipline with a minimum of 10 years relevant industrial experience
- Alternatively, Ph. D. in Organic Chemistry, Analytical Chemistry, Chemical Engineering, Pharmaceutical Science or related discipline with 7 years of industrial experience
- Demonstrated expert knowledge in DS and/or DP manufacturing and scale-up of small molecule compounds (organic chemical synthesis, crystallization, chromatography, filtration, precipitation, drying, API formulation, spray drying, milling & micronization, API physical characterization, blending, compaction, film-coating, encapsulation, tableting and typical analytical tests for OSD products).
Director, CMC Team Leader Small Molecule Programs - Redwood City, United States - Rezolute, Inc
