锦鲤求职岗位描述
岗位职责
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.
岗位要求
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.