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无工作经验 -
招1人 -
02-09 发布
职位描述
Director/Senior Manager: AnalyticsLocation: ShanghaiPosition: Full TimeChimagen is seeking a highly experienced and motivated Director/Senior Manager of Analytics to lead the QC group. The position will initially work primarily with third parties (e.g. CROs and CMOs). The candidate will provide analytical method expertise in analytics of therapeutic proteins and monoclonal antibodies to Chimagen commercial QC network, drive ### initiatives including standardization, automation and new technology introduction. The candidate will also monitor commercial method performance and provide method improvement and troubleshooting support to the QC sites. Furthermore, this individual is expected to work independently on assigned tasks/projects, mentor scientists, and provide insight to improve processes, and communicate results to the CMC team. Essential ResponsibilitiesDevelop and execute plans for the development, optimization, validation, implementation and maintenance of QC test methods for commercial biologic products following cGMP regulations, regulatory guidelines as well as local and global quality standards Lead investigations across the entire Roche/Genentech global QC network (including CMOs and partners) Apply technical knowledge, scientific experience and expert judgment to address a broad range of difficult analytical problems Troubleshoot and direct the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships Design and execute studies to assess technical suitability of new technology in QC environment Author technical study protocols/reports and method validation protocol and reports with minimal supervision Serve as an analytical method SME, response to health authority questions on methods Own global methods and serve as change owner for global method release and revision Monitor method performance in the QC and implement improvement measures to enhance QC Right First Time rate Support Analytical Technical Leaders for product control system life cycle management Spend approximately 50% of the time in the lab, and work on site during normal business hours to ensure adequate interaction with other lab staff and management, and execution of lab studiesEducation and Experience M.S. or Ph.D.(preferred) in Analytical Chemical, Physical Chemistry, Biochemistry or related fields 8+ years (M.S.) or 5+ years (Ph.D.) of experience in pharmaceutical, diagnostic or other GMP regulated industriesHas in-depth knowledge, hand on experience and expertise on biologics drug substance and drug product analytical methods including scientific theories, principles and techniques Able to work with QC labs across QC network to trouble shoot iOOS and other technical issues of the methods Able to address HA questions in the methods with limited direction and supervision Able to performing method development, improvement, validation and GMP testing Knowledgeable of and experienced in cGMP, compliance, and regulatory requirements for biopharmaceuticals Experience with Labware LIMS, Trackwise, Change Control and other quality systems, can be CAPA and CR owner with minimal direction Strong written and verbal communication skills with proven record in protocol, report and deviation/CAPA writing Highly motivated and self-driven i with the ability to work with minimal supervision to schedule, track, review, and report progress Excellent resource and task planning and prioritization skills with the ability to deliver high quality results per planned timelines Knowledge of and experience with cGMP, compliance, and regulatory requirements for biopharmaceuticals are required Able to work in the lab approximately 50% of the time, and able to work on site at normal business hoursStrong oral presentation and communication skills.Ability to communicate in English. 职能类别： 生物工程/生物制药 医药技术研发管理人员
联系方式
蔡伦路780号
公司信息
上海恩苜生物科技有限公司诚聘
