Associate Director/ Senior Principal Scientist

1. 01

   ADC Late-Stage Process Optimization- Lead late-stage process optimization for ADC drug substance (DS) manufacturing processes, including conjugation, purification, formulation and other critical unit operations.- Design and execute process optimization studies using statistical methods (e.g., Design of Experiments, DOE) to identify critical process parameters (CPPs), optimize process conditions, improve product yield, purity, and consistency, and enhance process efficiency and scalability.2. Process Characterization & Validation Support- Lead the process characterization for ADC drug substance (DS) manufacturing processes, including conjugation, purification, formulation and other critical unit operations. Draft the process characterization protocols execute risk assessments for process parameters, establish design space for critical processes, and generate robust process characterization reports to support regulatory filings and process validation.- Collaborate with validation teams to support process performance

(PPQ) and commercial process validation, provide technical expertise to ensure processes meet GMP requirements and commercial manufacturing standards.Required Qualifications1.Academic Background: PhD degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Molecular Biology, or a related scientific discipline, with training in conjugation process characterization or experience in mab process characterization projects.2.Work Experience: 3-5 years of progressive professional experience in biopharmaceutical/ADC process characterization.3.Technical Expertise: In-depth knowledge of ADC manufacturing processes, including antibody conjugation, purification with hands-on experience in late-stage process optimization and characterization.- Thorough understanding of ICH guidelines, GMP requirements, and global regulatory expectations for biologic/ADC process development and characterization.- Proficiency in statistical process design (DOE), risk assessment tools, process characterization methodologies, and data analysis for process robustness evaluation.- Familiarity with ADC critical quality attributes (CQAs), critical process parameters (CPPs), and design space establishment.4.Leadership & Management: Demonstrated experience leading technical teams; exceptional team leadership, communication, and interpersonal skills.5. Proficient English communication skills, including reading, listening, writing, and speaking.Personal Growth/Career Development1.Embrace a multi-level, diversified talent training and development system of WuXi XDC’s, comprehensively developing general skills, technical capabilities and leadership.2.Gain extensive technical experience for biopharmaceutical process development and analysis through WuXi XDC’s global technology platform.3.Accumulate abundant CMC project experiences in a few years, not only in process development, but also in protein analysis, manufacturing and regulation submissions.Have chance to learn, work and grow with WuXi XDC in long-term development.