【杭州 MSAT副总监/总监招聘】-猎头顾问杭州招聘信息-猎聘

李先生 4小时前在线已认证

猎头顾问 · 成都特威麟企业管理有限公司

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职位介绍: Key Responsibilities 1. Leadership and Team Management Support MST Head to lead cross-disciplinary teams across Suzhou & Hangzhou sites. Build collaborative, high-performance teams matching corporate objectives & staff career development. Identify, mentor high-potential talents and complete internal succession planning. 2. Regulatory Support Oversee drafting of NDA/BLA process-related regulatory submission dossiers. Ensure all technical documents comply with global regulatory standards. Cooperate with RA, QA and relevant departments to guarantee approval and smooth regulatory inspections. 3. Downstream Process Expertise Provide full technical oversight & troubleshooting for downstream purification/formulation of mAb, bispecific, ADC and peptide products. Serve as core technical expert during regulatory audits to reply downstream-process related queries. 4. Operational Oversight and Compliance Ensure MST daily activities comply with GMP, ICH and internal quality standards. Lead continuous improvement projects to optimize process stability, production efficiency and product quality. Track team performance & resource allocation to fulfill project and corporate targets. 5. Stakeholder Collaboration Act as key MST coordinator to connect R&D, Production, RA, QA and other cross-functional departments. Provide technical leadership for manufacturing tech transfer, process scale-up and validation. Represent Innovent to communicate with external regulators and industrial partners. 6. Strategic Contribution and Reporting Participate in company’s manufacturing & regulatory strategic planning for business expansion. Compile technical reports, KPI updates and present progress to senior management regularly. Requirements and Qualifications Education Master or PhD degree in Biochemistry, Biochemical Engineering, Biotechnology or related disciplines. Experience ≥8 years biopharma manufacturing experience focusing on downstream bioprocess. Proven experience managing technical teams; multi-site management background preferred. Practical experience in NDA/BLA regulatory submission preparation. Technical Expertise In-depth mastery of downstream technologies: purification, filtration, formulation. ADC production experience is preferred; upstream process knowledge is a bonus. Solid command of global biomanufacturing regulations including GMP & ICH guidelines. Skills Outstanding leadership, communication and team development capability. Strategic thinking & problem-solving competence focused on operational excellence. Strong multi-project management ability under fast-paced working environment. Business fluent English for global cross-border communication. Preferred Qualifications Direct experience compiling NDA/BLA technical submission documents. Know-how of advanced manufacture: continuous bioprocess, single-use system etc. Proficiency in digital tools for process monitoring, data analysis & production efficiency upgrade. Work Location Based in Suzhou or Hangzhou; frequent business travel between two sites required.