? Ongoing customer TT project following up and troubleshooting support, Lead project team archive target with Qualified Target as well as Timeline.
? Execute and complete the contract of Technology transfer, Work with RU(Licence out and SU(License in) make the project schedule of TT implement , management the project go with Target result.
? Familiar with Tools of Tech Transfer(such as Development Report, Demo Report, Process Description, Raw Data, Process Control Trends, Process Flow Diagrams, Bill of Material, Risk Assessment)
? Understand Process Development, Tech Transfer to Manufacturing, Scale-up Run.
? Connect with Tofflon BD team, support the trouble shooting during our production (Such as SUS, Consumables application) .
? Assist in strategy of Technology Transfer, Engineering, Machine as well as consumables sales, for BioPharma
? Master degree in Biologic or pharmaceutical or chemical Engineering with a minimum of 10 years’ working experience in biopharmaceutical field. 5+ years in Project Management experience.
? With execution experience of DS technology transfer to Oversea.
? With strong Product and Process Knowledge, Pharmaceutical Quality System. Understand CQAs and CPPs to enable a Control Strategy to be developed.
? Familiar with the regulation and Guidance for TT relented Process &Material Change Control(ISPE,PDA,WHO,ICH)
? Stonge communicate skill and Ability to manage complex projects and multi-task.
? Able to using MS Porject,Outlook, software Microsoft PPT preparing Slides、AutoCAD,Vision for PFD review.
? Willing and able to travel (normally 30% of the time)
? Working/Study experience in oversea, Fluent in English, verbal and written
? With PMP or PgMPcertificate will be great.