表征研究员/Research Investigator, Characterization(博士岗)

表征研究员/Research Investigator, Characterization(博士岗) 发布于 2026-03-17 Tech Ops and Manufacturing Tech Ops and Manufacturing | 全职 全职 | 北京市 北京市 General Description:The Analytical Research and Development (AR&D) department in biological CMC Technology Development of BeOne plays a critical role in supporting the advancement of biotherapeutic programs from early discovery through commercial readiness. Its major functions include developing, optimizing, and qualifying, and transferring of robust analytical methods to analyze complex biological molecules, such as multi-specific antibodies and ADCs for identity, purity, potency, and stability. AR&D also conducts in‑depth structural and functional analyses to ensure product consistency and compliance with regulatory expectations. The team provides analytical support for process development, formulation, and scale‑up activities, as well as generates essential data for comparability, release testing, and stability studies. In addition, AR&D contributes to regulatory filings by preparing structural characterization, method descriptions, specification justifications, and analytical summaries that demonstrate product quality throughout the development lifecycle.Job Description (including but not limited to):1)Support early-stage and late phase biological product development. Responsible for drug substance and drug product characterization, comparibility and tech transfer.2)As function representative, working closely with stakeholders (technical development functio, s, 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 state-of-art mass spectrometry 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.Qualification:1)PhD in chemistry, pharmaceutical sciences, biochemistry, chemical engineering, or relevant field.2)Proficient experimental skills, capable of independently completing study design, experiment execution, data collection and analysis, as well as report writing, and able to troubleshoot abnormal experimental results.3)Familiar with mass spectrometry methodologies and equipment, e.g., intact MS analysis, peptide mapping, disulfide analysis, post-translational modification analysis and native MS.4)High self-motivation to solve problems and explore state-of-the-art technologies.5)Good English proficiency (reading/writing/speaking) for technical communication, documentation and cross-functional collaboration.6)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.7)Hands-on experience in automated equipment operations is a plus, e.g., automated liquid handling workstation.8)Experience in applying AI tools to improve real work outcomes, with clear examples of impact (quality, spee

d, decision support) is a plus. General Description: The Analytical Research and Development (AR&D) department in biological CMC Technology Development of BeOne plays a critical role in supporting the advancement of biotherapeutic programs from early discovery through commercial readiness. Its major functions include developing, optimizing, and qualifying, and transferring of robust analytical methods to analyze complex biological molecules, such as multi-specific antibodies and ADCs for identity, purity, potency, and stability. AR&D also conducts in‑depth structural and functional analyses to ensure product consistency and compliance with regulatory expectations. The team provides analytical support for process development, formulation, and scale‑up activities, as well as generates essential data for comparability, release testing, and stability studies. In addition, AR&D contributes to regulatory filings by preparing structural characterization, method descriptions, specification justifications, and analytical summaries that demonstrate product quality throughout the development lifecycle. Job Description (including but not limited to): 1)Support early-stage and late phase biological product development. Responsible for drug substance and drug product characterization, comparibility and tech transfer. 2)As function representative, working closely with stakeholders (technical development functio, s, 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 state-of-art mass spectrometry 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. Qualification: 1)PhD in chemistry, pharmaceutical sciences, biochemistry, chemical engineering, or relevant field. 2)Proficient experimental skills, capable of independently completing study design, experiment execution, data collection and analysis, as well as report writing, and able to troubleshoot abnormal experimental results. 3)Familiar with mass spectrometry methodologies and equipment, e.g., intact MS analysis, peptide mapping, disulfide analysis, post-translational modification analysis and native MS. 4)High self-motivation to solve problems and explore state-of-the-art technologies. 5)Good English proficiency (reading/writing/speaking) for technical communication, documentation and cross-functional collaboration. 6)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. 7)Hands-on experience in automated equipment operations is a plus, e.g., automated liquid handling workstation. 8)Experience in applying AI tools to improve real work outcomes, with clear examples of impact (quality, speed, decision support) is a plus. 校招项目-2026春招允许投递2次，请选择适合的职位进行投递 立即投递