(高级)制剂科研员,小分子CMC(硕士岗)
beigene · 苏州市, 江苏, 中国
About The Role
Essential Functions of the job: Design with moderate support and independently conduct physicochemical characterization of new chemical entities, animal formulation development, and developability assessment (Preformulation) Design with moderate support and independently perform experiments for formulation and process development/understanding/optimization (FORMULATION) Independently interpret experimental results and present results and conclusions in cross functional meetings Keep good record of work per the company policy, prepare technical reports; contribute to regulatory filing with the supervision Solve routine technical problems Support drug product development of new chemical candidates from FIH to commercialization As preformulation / formulation lead, closely collaborate with cross functional CMC team members to deliver overall project goals with supervision Education Required: Master degree with hands-on experience in drug product development; innovator drug development experience is highly preferred Other Qualifications: Good in general technical practice for drug product development. Willing to learn and apply scientific principles to execution of daily responsibilities Good in oral solid product development, and perform bench & pilot-scale manufacturing unit operations, such as blending, milling, roller compaction, wet granulation, fluid-bed drying, capsule filling, tablet compression and film coating; experience in hot melt extrusion and spray drying is highly preferred (FORMULATION) Good in material science testing of particles, powders and compacts, including but not limited to particle size, flowability, density, tablet mechanical strength, and disintegration (FORMULATION) Develops and applies basic principles and scientific concepts to execute work in a laboratory or pilot plant environment to advance new solid oral drug products Strong capability of data analysis and interpretation Operate and trouble shoot instruments and processes Adequate capability in written and spoken English and capable of preparing technical reports in English Good interpersonal skills in both verbal and written communication, and be able to effectively communicate with the team or cross-functional teams
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