R&D Scientist/Engineer

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
Whatwillthe