Process Sciences Analytical Lead応募後で応募 求人ID R0036953 掲載日 06/15/2021 Location:Singapore, Singapore
Primary Objectives of this Job
• Lead the analytical activities within the Singapore (SN) Manufacturing Sciences (MSci) lab: implement and manage analytical testing (test methods, analysis, testing equipments) for any lab experiments in support of (including and not limited to) new production introduction, technology transfer, small scale validation, process improvements and process investigations.
• Coach the analytical laboratory personnel in analytical techniques and testing.
• Lead and project manage the implementation of analytical activities in SN MSci lab from purchase of equipment, commissioning and to method transfer (including feasibility studies) from analytical development and/or Neuchetel and Orth QC labs.
• Coordinate with cross functional teams including within MSci or with global function (for eg, Pharm Sci, analytical development) to design required analytical studies/testing, coordinate timelines and analytical activities to support global and local process improvements projects or process investigations or material use tests for commercial manufacture.
• Implement analytical methods to support end to end small scale processing for current manufacturing processes on site (for eg, Advate, Rixubis, TAK-755) and for any new manufacturing processes to be transferred to the site (for eg, Vonvendi). Develop and improve analytical methods to support these activities.
• Manage routine maintenance of analytical equipments, methods and testing for lab activities to support process improvements and investigation, new product introduction and technology transfer.
• Perform troubleshooting of analytical testing issues and analytical equipment issues within the SN MSci lab.
• Train Process Sciences analytical Engineer I/II to perform analytical testing within the SN MSci lab.
• Ensure that laboratory documentation including procedures, forms, protocols and reports for routine analytical activities and / or testing are created and reviewed according to relevant quality standards.
• Review and approve analytical reports generated from SN MSci lab.
• Participate in Community of Practice, where applicable, and implement any analytical improvements and/or global analytical initiatives.
• Support EHS audit walkdowns, and ensure that audit CAPAs are closed on time.
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
• Any other duties as assigned by supervisor.
Education and Experience Requirements
• Bachelor’s degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, Biochemical Engineering with minimum 6 years of relevant experience or Master’s/PhD degree with 4 years of relevant experience.
• Experience with analytical development, testing, troubleshooting for biological manufacturing processes either in manufacturing or in small scale environment, including and not limited to, HPLC, spectroscopy analyses, bioanalytical assays, etc.
• Experience with analytical method development, planning and lab scheduling.
• Strong project management skills will be an added advantage.
Key Skills and Competencies
• Strong knowledge of laboratory planning and scheduling
• Strong technical expertise in analytical techniques including testing, method implementation and troubleshooting, with ability to coach the team
• Good knowledge of GLP
• Team player /able to work in matrix environment
• Proactive and independent worker/ self starter
• Strong analytical skills including critical, objective/logical thinking
• Good oral, written communications (to write technical and scientific reports) and presentation skills