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: 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 Doyouthinkthisroleisnotforyou? StayconnectedwithAlgenexandfollowourupcomingopportunities.
Therightnextstepinyourcareermightbejustaroundthecorner. EQUALOPPORTUNITYCOMMITMENT AtAlgenex,weareco