DS MSAT技术转移与工艺验证专家-下游-无锡

Technical Leadership • Serve as a Subject Matter Expert (SME) for upstream cell culture and/or downstream purification processes. • Lead complex technical investigations and root cause analyses for manufacturing deviations, process excursions, and product quality issues. • Drive technical solutions and risk assessments to ensure robust and compliant manufacturing operations. • Support technology transfer, process scale-up, process optimization, and lifecycle management activities. Process Investigation & Troubleshooting • Lead cross-functional investigations involving Manufacturing, Quality, Process Development, Engineering, and Supply Chain. • Apply scientific and statistical approaches to identify root causes and define effective CAPAs. • Utilize structured problem-solving methodologies and investigation tools. Process Characterization & Validation • Provide technical support and oversight for: o Process Characterization Studies (PCS) o Process Performance

(PPQ) o Continued Process Verification (CPV) o Comparability and process change assessments • Ensure process understanding is translated into robust control strategies and validation approaches. Data Analysis & Scientific Decision Making • Apply statistical methodologies and data analytics to support process understanding and decision-making. • Analyze large manufacturing and development datasets to identify trends, correlations, and process risks. • Utilize statistical software and tools for process evaluation and monitoring. Collaboration & Communication • Act as a key technical interface with internal stakeholders and external clients. • Prepare and present technical reports, investigation summaries, and regulatory support documents. • Provide technical mentorship and coaching to junior scientists and engineers. ________________________________________ Qualifications Education • MS or PhD in Biotechnology, Biochemical Engineering, Chemical Engineering, Biology, Pharmaceutical Sciences, or related disciplines. Experience • Minimum 5 years of hands-on experience in biologics process development, manufacturing support, MSAT, or related functions. • Strong expertise in either: o Upstream processing (cell culture, seed train, bioreactor operations, process development), and/or o Downstream processing (chromatography, filtration, viral clearance, purification process development). • Extensive experience supporting commercial manufacturing and/or late-stage process development activities. • Demonstrated experience leading complex deviation investigations and technical troubleshooting efforts. Technical Competencies • Deep scientific understanding of biologics upstream and/or downstream processes. • Strong knowledge of: o Process development o Process characterization o Process validation (PPQ/PV) o Process control strategies o GMP manufacturing operations • Familiarity with statistical concepts and tools, including: o DOE o Statistical Process Control o Regression Analysis o Multivariate Data Analysis o Trend Analysis • Proficiency with statistical software (e.g., JMP, Minitab, SAS, R, or equivalent). Skills • Excellent analytical thinking and logical problem-solving skills. • Strong scientific writing and technical documentation capabilities. • Excellent communication and stakeholder management skills. • Fluent in both written and spoken English and Chinese. ________________________________________ Preferred Qualifications • Experience supporting commercial biologics or late-stage development programs. • Experience interacting with regulatory agencies or supporting regulatory inspections. • Experience leading cross-site, global, or cross-functional technical initiatives. • Ability to influence and drive decisions through scientific rationale and data-driven approaches.