Top Job Responsibilities: 1. Provide global technical leadership to oversee and streamline CPV strategy and practice within company global MFG network and across projects including routine statistical control chart creation and process performance monitoring; assess the process capability relative to specifications, CpK, PpK; conduct regular quality reviews; flag out abnormal fluctuation of process parameters and/or product quality attributes; support deviation investigation 2. Provide support during regulatory and ******s audits and guide the team in addressing CPV-related audit findings 3. Lead a group of scientists in implementing advanced data analytics, statistical modeling, multivariate statistical in support of manufacturing performance monitoring, prediction, control and real-time release 4. Led development and implementations of an integrated process monitoring and control system to maximize the value of data in support of manufacturing 5. Identify areas for continuous manufacturing improvement and optimization 6. Promote good customer relationship and explore customer business needs to support contract proposal and discussion for late-stage projects 7. Adept in promoting a culture of data-driven decision making across the organization 8. Provided coaching, mentorship, training, engagement and collaboration opportunities to enhance data resources collaborations 9. Working knowledge of in-silico modeling to identify opportunities for improving process performance and/or robustness through mechanistic modeling, artificial intelligence (AI), machine learning, or deep learning approaches Opportunities: 1. Join a highly dynamic CRDMO company with locations in China, APAC, Euro and USA 2. Working with cross-function teams with deep scientific and GMP manufacturing expertise 3. Offered opportunities to utilize and develop your lifecycle CMC experience in the pharmaceutical industry from process develop, tech transfer, and commercialization 4. Develop strong leadership and communication skills to facilitate contributions from different functions Required Qualifications: 1. Advanced degree (PhD or MS) in Statistics, Mathematics, Bio/chemistry, Bio/chemical Engineering, Biotechnology, Life Science or related major with 10+ years of applicable work experience 2. Extensive knowledge of pharmaceutical development, process development methodologies, manufacturing operations, manufacturing process analytics and control 3. Good experience and knowledge from biotech industry on data processing and statistical analysis, regulatory requirement on CPV, CMC strategy, risk and resource management, tech transfer, process qualification, deviation investigation and life cycle management 4. Excellent project management and communication capability 5. Be willing and able to work in China and other countries Preferred Qualifications: 1. Experience in two or more functional areas in Statistics, Data analysis, Project Management, Cell Line Development, Cell Culture, Purification, Analytical, Formulation, Manufacturing, Manufacturing Support, QC or QA in the biologics industry 2. Ability to effectively work across all levels, functions, and sites 3. Excellent verbal and written communication skills in both English and Chinese 4. Ability to work on multiple late-stage and commercial projects at the same ti******************