Research Investigator, Biologics Formulation

The Bio TD formulation team is seeking a highly motivated and experienced individual for Formulation & Drug Product Development team at Shanghai site. The successful candidate will contribute to formulation and DP development of BeOne’s biological product such as antibody, ADC. The ideal candidate will have expertise in all common formulation and drug product unit operations, as well strong critical thinking skills, and an ability to propose scientific solutions to address technical challenges. Responsibilities (including but not limited to)： 1) Lead the development of a robust formulation and DP process to support early-stage and late phase biological product development. Responsible for formulation and drug product process development and tech transfer. 2) As function representative, working closely with stakeholders (technical development functions, Research, CMC, Quality, MST/manufacture, Reg CMC, clinical operation, etc.) to advance technical development of newly NMEs according to aligned development timeline. Enable IND/BLA submission per aligned CMC timeline. 3) Key contributor to relevant CMC sections in IND/BLA submission. 4) Stay current with emerging trends, lead formulation and DP process platform establishment and optimization through introducing new technology or improving operation excellence. 5) Provide solution/insights on technical issues from biologics developability assessment to CMC development. Professional requirements: 1) PhD in pharmaceutical sciences, biochemistry, chemical engineering, or relevant field with above 1 year’s industrial experience. 2) Proven experience in end-to-end formulation development of biological products, such as antibody and ADC, experience in high concentration formulation development is a plus. 3) Hands-on experience in fill/finish process development, experience in process characterization is a plus. 4) Experience in authoring and reviewing development reports, SOPs, and batch records. 5) Familiar with CMC development workflow and concept. Familiar with formulation methodologies and equipment. 6) Hands-on experience in automation workflow development and/or automated equipment operation/integration in formulation or process development settings is a plus. 7) High self-motivation to solve problems and explore state-of-the-art technologies. 8) Good English proficiency (reading/writing/speaking) for technical communication, documentation and cross-functional collaboration. 9) Ability to work independently, identify, and solve problems. Strong interpersonal skills with a good collaboration spirit. Result-driven with high agility in a changing 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 BeiGene 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。 BeiGene 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 BeiGene’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 BeiGene Job Applicant Privacy Policy (BeiGene 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 BeiGene Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.