锦鲤求职岗位描述
Why Join WuXi XDC
Lead on a Global Platform
Accelerate Commercial Growth
Grow into a Global Technical Leader
Build and Transform at Scale
Partner with Industry Innovators
Position Summary
We are seeking a visionary and experienced Head of MSAT to provide strategic and technical leadership for commercial manufacturing within a rapidly growing global biologics and bioconjugate CRDMO organization.
This role will oversee technology transfer, process validation, manufacturing sciences, lifecycle management, Continued Process Verification (CPV), and commercial manufacturing technical support activities.
The incumbent will lead a large-scale technical organization comprising scientists, engineers and technical leaders, driving manufacturing excellence, regulatory compliance, technical innovation and commercialization success across global manufacturing networks.
Key Responsibilities
1. MSAT Organization Leadership & Talent Development
Lead the overall operation and management of the MSAT organization, ensuring efficient execution of departmental objectives and alignment with company strategy.
Oversee departmental planning, resource allocation, recruitment, succession planning, performance management and organizational development.
Establish and continuously improve MSAT training and SME development programs to ensure sustainable capability building.
Conduct competency assessment, talent reviews and development planning to strengthen technical and leadership capabilities across the organization.
Foster a high-performance, collaborative and quality-focused culture.
2. Technology Transfer, Process Validation & Commercial Manufacturing Support
Lead technology transfer, scale-up, process validation and PPQ execution activities for monoclonal antibodies and biologics drug substance manufacturing programs.
Ensure all technology transfer and validation activities are delivered on schedule, with high quality and in full compliance with GMP requirements.
Establish and continuously optimize technology transfer and process validation platforms to support commercial manufacturing readiness.
Provide technical leadership and support for GMP manufacturing campaigns, ensuring successful execution of engineering, validation and commercial batches.
Drive process robustness and manufacturing success through effective troubleshooting and technical problem solving.
3. Manufacturing Science, Laboratory Management & Technical Support
Lead MSAT laboratory operations and ensure effective support of GMP manufacturing activities.
Oversee use tests, process characterization, scale-up studies, engineering runs, technology transfer runs and troubleshooting activities.
Provide scientific and technical expertise to resolve manufacturing challenges and improve process performance.
Promote scientific innovation and implementation of advanced manufacturing technologies where appropriate.
4. Regulatory Compliance, Inspection & Quality Systems
Ensure GMP readiness across all MSAT functions and support regulatory compliance initiatives.
Lead preparation and management of customer audits and regulatory inspections.
Coordinate inspection responses, remediation plans and CAPA implementation.
Partner with Quality teams to ensure adherence to global GMP standards and quality management systems.
5. New Product Introduction & Cross-functional Leadership
Lead technical assessment and onboarding of new client programs and manufacturing technologies.
Drive process fit evaluations, manufacturing readiness assessments and GMP implementation activities.
Collaborate closely with Development, Manufacturing, Quality, Supply
Chain, Regulatory Affairs and Project Management teams.
Act as the primary technical leader to resolve complex cross-functional issues and facilitate effective decision-making.
6. Operational Excellence & Continuous Improvement
Drive operational excellence and continuous improvement initiatives across the MSAT organization.
Optimize workflows, resource utilization and project execution efficiency through structured methodologies such as WBS and Lean management principles.
Establish metrics and performance indicators to monitor organizational effectiveness and operational performance.
Promote a culture of continuous improvement, innovation and accountability.
Qualifications
1. Education
PhD preferred, Master's degree or above in Chemical Engineering, Bioengineering, Biotechnology, Biology, Pharmaceutical Sciences, or other related life sciences and engineering disciplines.
Significant international education, working, or leadership experience is highly preferred.
Demonstrated ability to operate effectively within a global and multicultural business environment.
2. Experience
10+ years of experience in biologics, biopharmaceutical, or bioconjugate manufacturing sciences, technical operations, MSAT, process development, or related technical functions.
Extensive experience supporting commercial manufacturing operations within the biotechnology, pharmaceutical, or CRDMO industry.
Demonstrated success leading technology transfer, process validation, PPQ execution, and manufacturing readiness activities.
Proven leadership experience managing technical organizations, cross-functional teams, and complex projects.
Strong project management capability with a track record of delivering technical programs in a GMP-regulated environment.
3. Technical Expertise
Deep expertise in monoclonal antibody (mAb) manufacturing, including upstream and downstream process technologies.
Strong knowledge of biologics drug substance manufacturing, technology transfer, process validation, scale-up, and GMP manufacturing support.
Solid understanding of pharmaceutical quality systems, including deviation investigations, CAPA, change control, risk management, and quality compliance.
Thorough knowledge of FDA, EMA, NMPA, ICH, and global GMP regulatory requirements.
Experience with bioconjugates, including ADC manufacturing and related technologies, is highly desirable.
4. Leadership Competencies
Strategic mindset with strong business acumen and organizational leadership capability.
Excellent communication, stakeholder management, and cross-functional collaboration skills.
Strong people leadership with demonstrated experience in talent development, coaching, and team capability building.
Results-oriented with a strong sense of accountability, execution excellence, and continuous improvement mindset.
Strong analytical thinking, problem-solving capability, and ability to perform effectively in a dynamic and fast-paced environment.
Excellent written and verbal communication skills in English, including meeting facilitation, presentation, and technical documentation.
Location：Wuxi, China