Analytical Development Scientist

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: o ELISA: direct, indirect, sandwich, inhibition and cell-based o In vitro Potency Assays o WesternBlot o SDS-PAGE o qPCR o 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 Doyouthinkthisroleisnotforyou? StayconnectedwithAlgenexandfollowourupcomingopportunities.
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