MSAT -

Key Responsibilities

• Lead end-to-end technology transfer for multiple biologics projects (upstream, downstream, fill-finish), defining phase-appropriate strategies and overseeing execution.
• Review and align cross-functional teams (PD, Manufacturing, QA / QC) on transfer documents including process descriptions, risk assessments, and analytical reports.
• Draft critical transfer documents such as gap analyses, protocols, and summary reports; track key milestones including materials, equipment, and batch records.
• Resolve deviations and change controls, drive root cause analysis (RCA), and implement CAPA.
• Provide process optimization recommendations for commercial manufacturing and support complex deviation investigations and process validation (PPQ).
• Author BLA / NDA submission documents including CMC sections and process validation reports; respond to global health authority (FDA / EMA / NMPA) queries.
• Assess regulatory impact of process changes to ensure full compliance.

Qualifications

• Ph.D. in Biopharmaceutical Engineering, Molecular Biology, Pharmaceutical Sciences, or related field.
• Research background in biologics process development (cell culture, protein purification, formulation stability) or GMP manufacturing.
• Published papers or patents in related fields (SCI journals preferred).
• Industry or academic project experience in GMP production or pilot-scale process scale-up.
• Knowledge of biologics manufacturing processes including mammalian cell culture, chromatography, UF / DF, and aseptic filling; understanding of critical quality attributes (CQAs).
• Familiar with technology transfer methodologies such as FMEA and QbD; knowledge of GMP / ICH guidelines.
• Experience in process validation or regulatory writing is a strong advantage.
• Systematic problem-solving ability with experience using DOE or statistical tools (e.g., JMP, Minitab).
• Able to clearly convey technical concepts to non-technical stakeholders.
• Effective in fast-paced environments, skilled at multitasking and managing priorities.
• Fluent in English (written and spoken); capable of drafting technical documentation and collaborating within global teams.

Location

Suzhou, Guangzhou, or Lianyungang, China