MSAT高级专家 20-40k
苏州-工业园区 5-10年 本科 招1人 6月16日更新
收藏
绩效奖金 餐费补贴 通讯津贴 五险一金
avator
盛女士 当前在线 已认证
招聘高级经理 · 信达生物
聊一聊
职位介绍
Key Responsibilities: 1. Leadership and Team Management: • Support the Head of MST in leading and managing a multidisciplinary team across Suzhou and Hangzhou sites. • Foster a collaborative, high-performing team environment that aligns with Innovent’s organizational goals and encourages professional development. • Identify and mentor high-potential individuals, preparing them for leadership roles and succession planning within Innovent. 2. Regulatory Support: • Oversee the preparation of regulatory submission materials, including process-related sections of NDAs and BLAs. • Ensure all technical documentation meets regulatory requirements and adheres to global standards. • Collaborate with regulatory affairs, quality assurance, and other teams to ensure successful approvals and compliance during regulatory inspections. 3. Downstream Process Expertise: • Provide technical oversight and troubleshooting for downstream manufacturing processes, including purification and formulation for mAbs, bispecific antibodies, ADCs, and peptides. • Act as a technical expert during regulatory audits and inspections, addressing downstream process-related inquiries and challenges. 4. Operational Oversight and Compliance: • Ensure all MST activities adhere to GMP, ICH guidelines, and Innovent’s internal quality standards. • Drive continuous improvement initiatives to enhance operational efficiency, process robustness, and product quality. • Monitor team performance and resource utilization to meet project objectives and organizational goals. 5. Stakeholder Collaboration: • Serve as a key liaison between the MST team and cross-functional stakeholders, including R&D, Operations, Regulatory Affairs, and Quality. • Provide leadership and technical guidance to enable successful technology transfer, scale-up, and validation of manufacturing processes. • Represent Innovent in discussions with external stakeholders, including regulatory agencies and industry partners. 6. Strategic Contribution and Reporting: • Contribute to Innovent’s strategic planning of manufacturing and regulatory activities to support continued growth and expansion. • Prepare and present updates, technical reports, and performance metrics to senior leadership and other stakeholders. 任职资格 Requirements and Qualifications: Education: • PhD or Master’s degree in Biochemistry, Biochemical Engineering, Biotechnology, or a related field. Experience: • Minimum of 8 years of industry experience in biopharmaceutical manufacturing, with intensive expertise in downstream processing. • Proven track record of managing and leading technical teams, preferably in a multi-site setup. • Experience supporting regulatory submissions, with specific knowledge of NDA and BLA preparation. Technical Expertise: • Deep understanding of downstream bioprocessing technologies, including purification, filtration, and formulation. • Experienced in ADC processing is a plus. • Familiarity with upstream processing is a plus. • Strong knowledge of regulatory requirements for biopharmaceutical manufacturing, including GMP and global regulatory guidelines. Skills: • Exceptional leadership and interpersonal skills to inspire and develop teams. • Strategic thinking and problem-solving capabilities, with a focus on operational excellence. • Strong project management and multi-tasking skills in a fast-paced, dynamic environment. • Fluency in English is required for effective communication in a global working environment. Preferred Qualifications: • Experience preparing technical documentation for regulatory submissions (e.g., NDAs, BLAs). • Knowledge of advanced manufacturing technologies, such as continuous bioprocessing or single-use systems. • Familiarity with digital tools for process monitoring, data analysis, and operational efficiency. Work Location: This position will be based in Suzhou or Hangzhou, with regular travel between the two sites.
其他信息
语言要求:英语、普通话
行业要求:全部行业

公司简介

关于信达 “始于信,达于行”,开发出老百姓用得起的高质量生物药,是信达生物的使命和目标。信达生物成立于2011年,致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物,让我们的工作惠及更多的生命。公司已有18个产品获得批准上市,它们分别是信迪利单抗注射液(达伯舒®),贝伐珠单抗注射液(达攸同®),阿达木单抗注射液(苏立信®),利妥昔单抗注射液(达伯华®),佩米替尼片(达伯坦®),奥雷巴替尼片(耐立克®), 雷莫西尤单抗注射液(希冉择®),塞普替尼胶囊(睿妥®),伊基奥仑赛注射液(福可苏®),托莱西单抗注射液(信必乐®),氟泽雷塞片(达伯特®),匹妥布替尼片(捷帕力®),己二酸他雷替尼胶囊(达伯乐®),利厄替尼片(奥壹新®),替妥尤单抗N01注射液(信必敏®),玛仕度肽注射液(信尔美®),匹康奇拜单抗注射液(信美悦®)和伊匹木单抗N01注射液(达伯欣®)。目前,4个新药分子进入III期或关键性临床研究,另外还有15个新药品种已进入临床研究。 玛仕度肽是信达生物自主开发的减重降糖创新药,其相关研究登顶《新英格兰医学杂志》《自然》主刊,成为全球减重降糖领域首个“双登顶”药物。作为信达生物在代谢疾病领域的重磅产品,玛仕度肽的推出为中国数千万糖尿病患者及肥胖人群带来突破性的治疗选择。 公司已与礼来、罗氏、武田、赛诺菲、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时,秉承经济建设以人民为中心的发展思想。多年来,始终心怀科学善念,坚守“以患者为中心”,心系患者并关注患者家庭,积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目,让越来越多的患者能够得益于生命科学的进步,买得到、用得起高质量的生物药。截至目前,信达生物患者援助项目已惠及20余万普通患者,药物捐赠总价值36亿元人民币。信达生物希望和大家一起努力,提高中国生物制药产业的发展水平,以满足百姓用药可及性和人民对生命健康美好愿望的追求。 详情请访问公司网站:www.innoventbio.com或公司领英账号www.linkedin.com/company/innovent-biologics/。
查看全部

猎聘温馨提示:

1. 如您发现平台内招聘方存在以下违规行为的,请立即举报
  • · 扣押您的身份证件或者其他证件;
  • · 要求您提供担保人、担保金或者以其他名义向您收取财物( 如培训费、体检费、资料费、置装费、押金等);
  • · 强迫您入股或者向您集资;
  • · 以招聘名义牟取不正当利益;
  • · 发布虚假招聘广告信息;
  • · 工作时长违反劳动法规定;
  • · 存在其他损害您的合法权益的行为。
2. 如您应聘的岗位属于涉外劳务合作/海外岗位的,请务必核实招聘方对外劳务合作资质取得情况,同时注意自身资金安全,防范招聘欺诈。
3. 本平台招聘方不向求职者提供任何收费服务。
查看全部

猜你喜欢

CMC经理/总监
苏州-工业园区
25-35k
某制药公司
制药 B轮 1-49人
史先生
associate consultant
MSAT工程师
上海
25-35k
某天津制药上市公司
制药 已上市 5000-10000人
李女士
组长
技术转移经理
苏州
29-35k
某国内制药上市公司
制药 已上市 5000-10000人
林女士
资深猎头顾问
1 2 3 4
更新时间:2026-08-14