Analytical Development Scientist (España)

Analytical Development Scientist (España)

22 oct
|
ALGENEX
|
España

22 oct

ALGENEX

España

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)
- Attractivesalarypa

📌 Analytical Development Scientist (España)
🏢 ALGENEX
📍 España

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