锦鲤求职岗位描述
Position Summary
We are seeking a highly experienced MSAT Process Expert to provide technical leadership in process troubleshooting, deviation investigation, process optimization, technology transfer, process validation, and continued process verification for commercial biologics manufacturing. The successful candidates will possess deep scientific understanding of upstream and/or downstream processes and have extensive experience in process development and manufacturing support within a GMP environment.
Key Responsibilities
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 Qualification (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.