Job purpose
Fully responsible for the strategic planning and operational management of the Mass Spectrometry, Characterization, and Bioactivity Non-GMP Development Center of Excellence. Lead a technical team of approximately 150-200 personnel and establish an integrated analytical technology platform covering bioprocess development through the preclinical stage. By defining technology roadmaps, driving innovative R&D, and optimizing service systems, ensure the center’s technological leadership and industry competitiveness in mass spectrometry analysis, physicochemical characterization, bioactivity assays, and more. Providing efficient, compliant, and high-quality technical support for global projects.
Responsibilities:
Strategic Planning and Platform Development:
- Develop mid- long term technology strategies and roadmaps for mass spectrometry, characterization, and bioactivity Non-GMP development, defining core technology directions (e.g., high-resolution mass spectrometry applications, complex protein characterization, novel bioactivity assay development). Lead platform technology upgrades and capability expansions;
- Build standardized, modular analytical technology systems; promote cross-technology collaboration and innovation, ensuring the platform meets diverse BU project needs (e.g., monoclonal antibodies, bispecific antibodies, fusion proteins, gene therapy drugs).
Team Management and Talent Development:
- Lead and manage a large technical team (including sub-teams in mass spectrometry analysis, physicochemical characterization, bioactivity assays, method development), optimize organizational structure to maximize people efficiency;
- Establish a top global talent pipeline; lead recruitment, development, and retention of core personnel; design dual career tracks for technical experts and management; build a team with innovative capability and industry vision.
Technical Services and Quality Compliance:
- Oversee provision of full-cycle analytical support for 300+ BU global projects, including but not limited to protein sequence confirmation, structural analysis, post-translational modification characterization, and bioactivity assays; ensure data accuracy, timely reporting, and compliance;
- Establish strict quality control systems; optimize lab workflows and SOPs; lead root cause analysis and improvement of technical deviations and issues to ensure stable service quality.
Technology Innovation and External Collaboration:
- Track cutting-edge global technologies in mass spectrometry, characterization, and bioactivity assays (e.g., AI-assisted analysis, ultra-high-resolution mass spectrometry, automated characterization platforms); lead new technology introduction, validation, and translational application; drive core technology patent portfolio development;
- Build internal and external technical collaboration networks; interface with leading academic institutions, industry partners, and regulatory bodies at home and abroad; participate in industry standard formulation to enhance the influence in global biopharmaceutical analysis.
Resource Coordination and Cross-Department Collaboration:
- Manage center budgets and key resources (instrumentation, consumables, manpower); optimize resource allocation to improve platform operational efficiency;
- Act as a key interface in BU analytical fields, collaborating deeply with R&D, process, quality, clinical departments to solve cross-functional technical challenges and promote achievement of key project milestones.
Requirements:
Education
Ph.D in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related fields; strong academic background with biopharmaceutical analysis major is preferred.
Experience
Over 15 years of experience in biopharmaceutical analysis, including at least 8 years team management experience ( hold technical management experience at least 100/team size).
Skills
- Proficient in mass spectrometry techniques (LC-MS, GC-MS, etc.), biopharmaceutical physicochemical characterization methods (e.g., SEC-MALS, CE-SDS, DLS), and bioactivity assay development at the non-GMP stage;
- Hands-on experience in the analysis of monoclonal antibodies and complex protein therapeutics;
- Familiar with the entire biopharmaceutical R&D process (early discovery → process development → pre-clinical);
- Deep understanding of analytical technical requirements and industry regulations (e.g., ICH, FDA guidelines) at the non-GMP stage；
- Proficient in biopharmaceutical analysis and relevant regulations; Excellent in biopharmaceutical CMC knowledge；
- Familiar with biopharmaceutical industry practices and regulatory requirements; possesses digital management mindset;
- Fluent language capabilities.