锦鲤求职岗位描述
Provide technical leadership to oversee and streamline CPV strategy for drug product and practice within company and across projectsPerform routine statistical control chart and process performance monitoring, assess the process capability relative to specifications, CpK/PpKconduct regular quality reviews, flag out abnormal fluctuation of process parameters and/or product quality attributes and support deviation investigationProvide support during regulatory and clients audits and address CPV-related audit findingsIdentify areas for continuous manufacturing improvement and optimizationProvided coaching, mentorship, training, engagement and collaboration opportunities to enhance data resources collaborationsRequired 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 experienceExtensive knowledge of pharmaceutical development, process development methodologies, manufacturing operations, manufacturing process analytics and controlGood 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 managementExcellent project management and communication capability