Principal Scientist, Biologics Formulation
beigene · 广州市, 广东, 中国
About The Role
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific, technical and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. This position is in Formulation and Drug Product Development Department in BeOne Medicine’s Biological Technical Development function. Within the department, the qualified candidate will be responsible for formulation development and characterization, developing drug products as well as aseptic fill finish process for BeOne’s biological molecules. Essential Responsibilities: Serve as a formulation lead to develop a robust formulation and DP process to for early-stage and late-stage biological programs, including antibody and ADC molecules. Responsible for formulation and DP process development and technology transfer. Act as a functional representative in cross-functional teams, and collaborate with key stakeholders (BioTD functions, research, CMC, Quality, MST/manufacture, Reg CMC, clinical operation, etc.) to advance the technical development of new biologics entities according to aligned program timeline. Enable IND/NDA/BLA submission per aligned CMC timeline. Provide technical support for GMP deviation investigations. Serve as a key contributor to author and/or review regulatory dossier for IND/NDA/BLA submission and regulatory interaction materials. Stay current with emerging formulation and DP development technologies. Evaluate state-of-the-art technologies and implement suitable ones in BeOne FDPD department. Lead formulation and DP platform establishment and optimization by introducing novel technology or improving operational excellence. Provide effective solutions to technical issues for biological products. May coach junior scientists in FDPD development work. Qualifications Required : PhD in pharmaceutical sciences, biochemistry, chemical engineering, or relevant field, with 0-2 years of experiences in formulation and/or DP development in the biopharmaceutical industry. Proficient experimental skills, able to independently design stability studies, execute experiments, interpret the data and draw scientifically solid conclusions. Familiar with formulation methodologies and equipment, such as MFI, DLS, visual inspection, viscosity, etc. is a plus. Demonstrated self-motivation with strong troubleshooting and problem-solving skills. Proficiency in English reading, writing, and speaking. Excellent interpersonal skills with a collaboration spirit. Results-driven with high agility in a dynamic environment. 百济神州全球胜任力 当我们通过以下十二项全球胜任力,展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时,我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明: 百济神州致力于尊重和保护您的个人信息权利,并承诺依据合法、正当、必要和诚信的原则处理您的个人信息(包括个人敏感信息 )。 由于百济神州在全球范围内开展业务,我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家(例如:美国)的服务器和数据库中,详情参见百济神州《求职者隐私政策》(百济神州官网 - 隐私政策 - 求职者隐私政策)。 如您主动向我们提供您的简历信息或其他个人信息,则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的,请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.
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