25 oct
|
ALGENEX
|
Madrid
AtAlgenex,wearepassionateaboutadvancingbiotechnologythroughthedevelopmentandmanufacturingofrecombinantproteinsfortheformulationofbiologicalmedicines.
WearecurrentlylookingforanAnalyticalDevelopmentScientisttojoinourteaminTresCantos,Madrid.Thisisagreatopportunityforascientificprofessionalwhowantstoplayanactiveroleinanalyticaldevelopmentwithinagrowingandinnovativeenvironment,contributingtoprojectswithrealimpactonthefutureofbiologicproducts.
Ifyouenjoycombiningscientificrigor,technicalproblem-solving,cross-functionalcollaboration,andhigh-qualityanalyticalworkinaregulatedenvironment,thisrolecouldbeyournextchallenge.
Whatarewelookingfor?
Descripción del puesto: Inanutshell Position:AnalyticalDevelopmentScientist Location:TresCantos,Madrid(On-site) Experience:3–5yearsofrelevantexperience Wanttoknowmore?
AtAlgenex,wearepassionateaboutadvancingbiotechnologythroughthedevelopmentandmanufacturingofrecombinantproteinsfortheformulationofbiologicalmedicines.
WearecurrentlylookingforanAnalyticalDevelopmentScientisttojoinourteaminTresCantos,Madrid.Thisisagreatopportunityforascientificprofessionalwhowantstoplayanactiveroleinanalyticaldevelopmentwithinagrowingandinnovativeenvironment,contributingtoprojectswithrealimpactonthefutureofbiologicproducts.
Ifyouenjoycombiningscientificrigor,technicalproblem-solving,cross-functionalcollaboration,andhigh-qualityanalyticalworkinaregulatedenvironment,thisrolecouldbeyournextchallenge.
Thechallenge
Executeandcoordinateanalyticaldevelopment,qualification,andvalidationactivitiesofmediumtohighcomplexity.
SupportdifferentstagesofAnalyticalDevelopmentand/orAnalyticalValidationwithahighlevelofautonomy.
Design,follow,review,andimproveanalyticalprotocols,methods,anddepartmentalprocedures.
Analyzeandinterpretscientificdata,ensuringtechnicalconsistencyandreliabilityofresults.
DocumentactivitiesandresultsaccuratelyandontimeinaccordancewithcGxP,regulatoryexpectations,andinternalprocedures.
Plan,execute,analyze,anddocumentstability,characterization,andvalidationstudies.
DraftandreviewtechnicaldocumentationsuchasSOPs,analyticalmethods,validationprotocols,stabilityplans,andtechnicalreports.
Designandexecuteanalyticalassaystosupportproductdevelopmentactivities,includingprocessdevelopment,formulation,characterization,andcomparability,whenapplicable.
Develop,qualify,andvalidateanalyticalmethods,includingexperimentalplanning,execution,dataanalysis,acceptancecriteriadefinition,conclusions,andrecommendations.
Generateandexecutevalidationandstabilityprotocols/plansandassociatedreports,includingsamplepointtracking,trending,andresultassessment.
Ensuretimelyandaccuraterecordingofresultsandobservations,maintainingdataintegrityandright-first-timedocumentation.
Review,consolidate,andapprovedocumentationandresultsgeneratedfromyourownactivitiesand,whenapplicable,performtechnicalpeerreviewofotherteammembers'documentation.
Ensurecompleteandconsistentrecords,traceability,andcompliancewithALCOA+principles.
Identifytechnicalissuesandproposecorrectiveandpreventiveactions.
Ensuretheappropriateuseandstatusofassignedanalyticalequipment.
Contributetolaboratoryinvestigations,includingOOS,OOT,anddeviations,whenapplicable.
Participateininternalandexternalanalyticaltransfers.
Keepelectronicnotebooks,rawdata,logbooks,andrelateddocumentationuptodate.
Supportonboardingandtechnicaltrainingofnewteammembers.
Collaborateeffectivelywithpeers,supervisors,andmanagementtocommunicateprogress,risks,andpotentialdeviations.
Providesupporttoothercompanyareasbasedonbusinessprioritiesandoperationalneeds.
Whatdoyouneed?
PhD, MS, BS, in Biotechnology, Biology, Biochemistry, Pharmacy or other disciplines related to Life Sciences.
Minimum3–5yearsofrelevantexperienceinthebiopharmaceuticalorbiotechnologyindustryinanalyticaldevelopment,analyticalvalidation,orqualitycontrol.
Strongknowledgeandhands-onexperienceinthedevelopment,qualification,andvalidationofanalyticalmethodsforbiologicalproducts.
Practicalexperienceworkingwithbiologicalsamplesandanalyticaltechniques,including:ELISA: direct, indirect, sandwich, inhibition and cell-based In vitro Potency Assays WesternBlot SDS-PAGE qPCR Otherrelevantanalyticaltechniques Experienceworkinginregulatedenvironmentsandhandlingtechnicaldocumentationaccordingly.
Strongscientificdataanalysisandinterpretationskills.
ProfessionallevelofEnglish.
ExperiencewithcGxP,ALCOA+,andmanagementofOOS/OOT/deviationswillbehighlyvalued.
Ourbenefits
Permanentcontract FlexiblestarttimefromMondaytoFriday(full-time) Attractivesalarypackage Lifeandaccidentinsurance Ticketrestaurant BenefitsandSavingsClub Trainingandlanguagelearningplatform Wellnessplatformwithunlimitedfreepsychologistsessions Developmentplansandinternalmobilitypolicy Manymore
Whatwilltheselectionprocesslooklike?
Initialcontactbyphone 2interviewstages Finalfeedbackattheendoftheprocess Doyouthinkthisroleisnot
📌 Analytical Development Scientist (Madrid)
🏢 ALGENEX
📍 Madrid