(Sr.) Principle Scientist, Late Stage Upstream Process Development

Serve as the upstream technical lead for assigned biologics programs, providing subject matter expertise and strategic guidance across all late-stage development activities. Drive workflow optimization and execution strategies to accelerate program timelines. Provide technical oversight for complex development challenges, ensuring scientific rigor in experimental design, execution, data analysis, and data-driven decision making. Lead process optimization initiatives to improve titer and fine-tune product quality, achieving CMC objectives for process robustness and cost of goods (CoGs) reduction within program timelines. Lead process characterization (PC) activities including risk assessment, scale-down model development and

, PC study and data analysis, and control strategy development. Partner with cross-functional teams, including MST, Downstream Process Development, Cell Line Development, Analytical Development, QA, QC, Regulatory Affairs, Program Management, and Manufacturing Operations, to ensure technical alignment and contribute to integrated CMC strategies, timelines, and milestones. Lead initiatives to develop and implement novel bioprocess platforms, maintaining competitiveness with evolving industry manufacturing trends and next-generation biologics technologies. Serve as the SME for critical upstream equipment, driving cross-site standardization and alignment with MST and Manufacturing to ensure consistent process execution and data comparability. Scale-up, technology transfer support for internal and external manufacturing sites, including deviation investigations, change controls, CAPAs, and product impact assessments. Drive PPQ readiness by translating process characterization knowledge into robust control strategies and process validation approaches. Author and review key CMC documents, including process development reports, PC protocols/reports, PV/PPQ protocols/reports, and regulatory submissions. Support regulatory inspections, dossier reviews, and health authority inquiries related to upstream process development, validation, and manufacturing. Qualifications & Skills Education & Experience PhD in Biology, Biochemistry, Chemical Engineering, or related field with ≥ 3 years of cell culture process development experience in biotech/biopharmaceuticals; OR BS/MS with 7 + years of relevant experience. Technical Expertise Deep understanding of CHO-based fed-batch processes, scale-up principles, and statistical tools. Hands-on experience with microbioreactors, bench-scale and pilot-scale bioreactors, and upstream tech transfer. Demonstrated success in developing and qualifying representative scale-down models, including resolution of complex technical challenges related to process scaling, model representativeness, and manufacturing relevance. Advanced proficiency in JMP software for Design of Experiments (DoE), process characterization, multivariate data analysis, statistical modeling, and design space development. Demonstrated success in late-stage upstream development, PPQ strategy design, tech transfer execution, and contributions to BLA submissions. Strong knowledge of regulatory expectations for process validation, control strategy, and commercial readiness. Soft Skills & Strengths Excellent communication, leadership, and cross-functional collaboration abilities. Proven initiative, creativity, and innovation in scientific problem-solving. Strong technical writing and critical-thinking skills. Ability to lead in a fast-paced, matrixed environment. Preferred Experience Experience with novel biologics such as bispecific antibodies , fusion proteins , enzymes , or other complex biologics is a plus. Why Join BeOne Lead high-impact late-stage and commercial biologics programs. Work in a collaborative, innovation-driven environment. Opportunities for scientific leadership, cross-functional visibility, and career advancement. 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. 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