13 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 Doyouthinkthisroleisnotforyou? StayconnectedwithAlgenexandfollowourupcomingopportunities.
Therightnextstepinyourcareermightbejustaroundthecorner. EQUALOPPORTUNITYCOMMITMENT AtAlgenex,wearecommittedtoequalopportunitiesandtofosteringadiverse,inclusive,andrespectfulworkplace. Allapplicationswillbeconsideredwithoutdiscriminationbasedongender,genderidentityorexpression,ethnicity,nationality,religion,sexualorientation,age,disability,oranyothercharacteristicprotectedbyapplicablelaw.
📌 R&D Scientist/Engineer (Madrid)
🏢 ALGENEX
📍 Madrid