Responsibilities:
•Provide technical leadership to oversee and streamline CPV strategy for drug product and practice within company and across projects
•Perform routine statistical control chart 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 and support deviation investigation
•Provide support during regulatory and clients audits and address CPV-related audit findings
•Identify areas for continuous manufacturing improvement and optimization
•Provided coaching, mentorship, training, engagement and collaboration opportunities to enhance data resources collaborations

Required Qualifications:
•Advanced degree (PhD or MS) in Statistics, Mathematics, Bio/chemistry, Bio/chemical Engineering, Biotechnology, Life Science or related major with 5+ years of applicable work experience
•Extensive knowledge of pharmaceutical development, process development methodologies, manufacturing operations, manufacturing process analytics and control
•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
•Excellent project management and communication capability