Zhuhai Director Upstream And Downstream Process Development GD 519080

Job description

Our Mission At BioNTech, we are committed to translating cutting-edge science into transformative therapies for patients worldwide. As we continue to advance our immunotherapy portfolio, we are seeking an experienced and visionary leader to drive process development strategies for our immunomodulator programs across clinical and commercial stages. Your Responsibilities As Director, Upstream & Downstream Process Development, you will provide scientific and organizational leadership for the development of robust, scalable, and compliant manufacturing processes supporting innovative biologics in preclinical and clinical stage. You will: Lead upstream and downstream process development activities including recombinant proteins, cytokines, fusion proteins, and other novel biologics. Lead Pre-Tox and phase I materials manufacturing. Drive process optimization to improve product quality, manufacturing robustness, yield, and cost efficiency. Define and establish Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and control strategies in alignment with Quality by Design (QbD) principles. Lead process characterization, validation, and lifecycle management activities to ensure manufacturing consistency and regulatory compliance. Oversee technology transfer from development into GMP manufacturing facilities and support scale-up initiatives across global manufacturing networks. Collaborate with the GTD team for all the innovation projects. Partner closely with Manufacturing, MSAT, Analytical Development, Quality, Regulatory Affairs, and Supply Chain teams to deliver key program milestones. Contribute to global regulatory submissions, inspections, and health authority interactions.Build, mentor, and develop a high -performing team while fostering a collaborative and innovative working environment. Who you are > 15 years of master's or > 10 years of Ph. D. in Biologics development; Extensive experience within biopharmaceutical process development and manufacturing.Hands-on experiences of biologics manufacturing processes, upstream (Preferred) or downstream. Demonstrated success in process scale-up, technology transfer, GMP manufacturing support, and late-stage development programs Familiar with the IND submission regulation for process development and manufacturing for the US/China; Strong stakeholder management skills and ability to build effective partnerships across local, global functions internally and externally 立即申请 » 查找类似职位: Alle Stellen, All Jobs Terms of Use General Terms and Conditions Data Privacy Statement Imprint Cookie Settings © 2024 BioNTech SE. All rights reserved Cookie 许可管理器 当您访问任何网站时，它可能存储或检索浏览器中的信息，大多数为 cookie 形式。我们尊重您的隐私权，因此您可以选择不允许某些类型的 cookie。但是，阻止某些类型的 cookie 可能影响您的网站体验以及我们能够提供的服务。 需要的 Cookie 需要这些 cookie 才能使用此网站，无法将其关闭。 需要的 Cookie 需要的 Cookie 提供者 描述 已启用 SAP as service provider 我们使用以下会话 cookie，使网站正常工作需要所有这些 cookie： "route" 用于会话粘性 "careerSiteCompanyId" 用于将请求发送至正确的数据中心 "JSESSIONID" 在会话期间位于访问者的设备上，以便服务器能够识别访问者 "Load balancer cookie"（实际的 cookie 名称可能不同）阻止访问者从一个实例跳转到另一个实例 需要来自提供者 SAPasserviceprovider 的 cookie，无法将其关闭 功能 Cookie 这些 cookie 可以通过记住您的登录详细信息、优化视频性能或提供有关如何使用网站的信息来在此网站上提供更好的客户体验。您可以随时自由选择接受或拒绝这些 cookie。请注意，如果您不接受这些 cookie，这些第三方提供的某些功能可能受影响。 同意所有 功能 Cookie 功能 Cookie 提供者 描述 已启用 YouTube YouTube 是一项视频共享服务，用户在此可以创建自己的档案，上传视频，以及观看、点赞和评论视频。选择拒绝 YouTube cookie 将无法观看 YouTube 视频或与其交互。 Cookie 政策 隐私政策 条款和条件 同意来自提供者 YouTube 的 cookie