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. 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.