MSAT Specialist

Overview Join a dynamic team focused on advancing the manufacture of biologics. Collaborate with cross-functional teams in Research and Development, Manufacturing, and Quality Assurance. Contribute to the improvement of process efficiencies and compliance with regulatory standards. Key Responsibilities Lead comprehensive technology transfer projects for biologic products, ensuring appropriate strategies are implemented at each phase. Coordinate with teams to review and conform transfer documents that include process descriptions, risk assessments, and analytical reports. Draft key documentation such as gap analyses, protocols, and summary reports, while tracking essential milestones involving materials, equipment, and batch records. Address deviations and change controls effectively, conducting root cause analysis (RCA) and executing corrective actions (CAPA). Provide recommendations for process optimization in commercial manufacturing and aid in complex deviation investigations and process validations (PPQ). Create BLA/NDA submission documents with strong emphasis on CMC sections and process validation, while responding to inquiries from global health authorities (FDA/EMA/NMPA). Evaluate the regulatory implications of process changes to assure compliance at all times. Qualifications Ph.D. in Biopharmaceutical Engineering, Molecular Biology, Pharmaceutical Sciences, or a related discipline. Experience in biologics process development (cell culture, protein purification, formulation stability) or GMP manufacturing. Publication record or patents in relevant fields (preferably in SCI journals). Hands-on project experience in GMP production or pilot-scale process scale-up. Familiarity with biologics manufacturing processes including mammalian cell culture, chromatography, UF/DF, and aseptic filling; understanding of critical quality attributes (CQAs). Knowledge of technology transfer methodologies such as FMEA and Quality by Design (QbD); familiarity with GMP/ICH guidelines. Experience in process validation or regulatory documentation is highly valuable. Strong analytical and problem-solving skills, with proficiency in statistical tools (e.g., JMP, Minitab) and design of experiments (DOE). Ability to communicate complex technical concepts clearly to a diverse audience. Thrives in fast-paced environments, with excellent multitasking and prioritization abilities. Fluency in English (both written and spoken), capable of drafting technical documentation and working collaboratively within global teams. Location Suzhou, Guangzhou, or Lianyungang, China