职位描述
职位描述:
Keyaccountabilities:
1.Executeseparationcampaigns,includingbatchseparationandpost-separationproductdry
2.FilluptheproductionbatchrecordtimelyandaccuratelyinaccordancewithGMP/GLPguidelines
3.Performinstrumentcleaningverificationandmaintaintheproperoperationoftheseparationsuite,particularlythecleanarea
4.Performinter-processpuritycheckbyanalyticaltools
5.AssistscientiststomaintaintheinstrumentsinpropercalibrationandworkingorderaccordingtotheappropriateSOP;helpperformingIQ/PQ/OQcalibrationsasassigned
6.Assistscientistsintrackingoftheplantmaterials,e.g.rawmaterials,solvents,intermediatesandfinalproductsetc.
Corebusiness/Functionalskillsandeducation:
1.MustbetrainedinorbefamiliarwiththerequirementsoftheFDAcGMP/GLPregulations,ICHguidelinesaswellasdrugdevelopmentprocess.
2.Diplomainchemistry,pharmaceuticalseparation,biochemistryorotherdirectly-relatedsciencedisciplinewithexperienceortraininginpharmaceuticalanalysis.
3.Musthaveexperiencewithstandardchromatography,bothpreparativeandanalyticaltechniques,particularlyHPLC;experience/familiaritywithseparationchromatographyinstruments.
4.Strongcommunicationskills,bothwrittenandverbal,andoutstandinginterpersonalskillsareessentialjobrequirements.
5.Mustbeabletoworkinateam-orientedmannerinordertoaccomplishperformanceobjectives.
公司介绍
药明康德新药开发有限公司于2000年12月成立,是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司,在中美两国均有运营实体。作为一家以研究为首任,以客户为中心的公司,药明康德向全球制药公司、生物技术公司以及医疗器械公司提供一系列全方位的实验室研发、研究生产服务,服务范围贯穿从药物发现到推向市场的全过程。药明康德的服务旨在通过高性价比、高效率的研发服务帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。
EstablishedinDecember2000,WuXiAppTecisaleadingglobalpharmaceutical,biopharmaceutical,andmedicaldeviceopen-accesscapabilityandtechnologyplatformwithoperationsinChinaandtheUnitedStates.Asaninnovation-drivenandcustomer-focusedcompany,WuXiAppTecprovidesabroadandintegratedportfolioofservicesthroughoutthedrugR&Dprocess.OurservicesaredesignedtohelpourworldwidecustomersshortenthediscoveryanddevelopmenttimeandlowerthecostofdrugandmedicaldeviceR&Dthroughcost-effectiveandefficientsolutions.