Bioanalytiker

DK - Temp-Team A/S; København; On-site; DKK 450,000 - 650,000; Full time

Job summary

Unilabs Pharma Solutions seeks an experienced Biomedical Laboratory Scientist/Bioanalyst to join a top-tier bioanalytical team in a commercial laboratory serving the pharmaceutical industry.

You will generate high-quality analytical data while ensuring compliance with GxP, GMP, and ISO 15189 standards, contributing to method development, validation, and continuous improvement.

Qualifications

• Degree as Biomedical Laboratory Scientist or equivalent.
• 2-5 years of experience in pharma/biotech/CRO or regulated labs.
• Experience performing bioanalytical testing in a GxP environment.
• Hands-on ELISA experience is required.
• Strong data integrity and documentation practices.

Responsibilities

• Perform routine and non-routine bioanalytical testing per SOPs and study protocols.
• Execute ELISA-based assays with high accuracy and consistency.
• Ensure timely delivery of analytical results with quality.
• Review data and documentation for completeness and compliance.
• Maintain samples receipt, processing, and analysis activities.

Skills

ELISA experience

GxP compliance

Data integrity

Documentation practices

Team collaboration

Education

Biomedical Laboratory Scientist degree or equivalent

Tools

ELISA

GxP instruments

Job description

Doyouthrivein alaboratoryenvironmentwherehigh-qualityanalyticalworkis at the center ofyourdailyresponsibilities?

On behalf ofUnilabsPharma Solutions, we are seeking anexperienced Biomedical Laboratory Scientist/Bioanalystto join a highly skilled bioanalytical teamin a commercial laboratory providing solutions for the pharmaceutical industry. This role is ideal for a laboratory professional who enjoys performing analytical testing in a regulated pharmaceutical environment while contributing to method improvements, validation activities, and the maintenance of quality standards.

AbouttheRole

Theprimaryfocusofthisposition is theexecutionofbioanalyticaltestingsupportingpharmaceuticalandbiotechnologyclientsthroughoutdrugdevelopmentprograms.Youwillberesponsibleforgeneratinghigh-qualityanalyticaldatawhileensuringfullcompliance withapplicableregulatoryrequirementsandqualitysystems.

Youwilljoin acollaborativelaboratoryteamwhereanalyticalexcellence,scientificrigor, andmeticulousdocumentationareessentialtosuccess.

AnalyticalTesting(PrimaryFocus)

• Performroutineand non-routinebioanalyticaltestingaccordingtoapprovedmethods,SOPs, andstudyprotocols.
• ExecuteELISA-basedassaysandotherbioanalyticalmethodswith a highdegreeofaccuracyandconsistency.
• Ensuretimelydeliveryofanalyticalresultswhilemaintainingthehighestqualitystandards.
• Reviewanalyticaldata anddocumentationforcompleteness,accuracy, and compliance.
• Perform samplereceipt,registration,processing, andanalysisactivities.

KeyResponsibilities

• Maintain,calibrate,troubleshoot, andverifythe performance oflaboratoryequipment,whilesupportingefficientlaboratoryworkflows andensuringlaboratoriesremaininspection-ready.
• Participateinmethoddevelopment,optimization,validation, transfer, andcontinuousimprovementofanalyticalmethodsandlaboratoryprocesses.
• Contributeto thequalification,implementation, andongoingoperation oflaboratoryequipment,technologies,assays, anddesignatedoperationalareas.
• Perform allactivitiesin compliance withGxPprinciples,includingGCP, GCLP, GMP, ISO 15189, andpharmaceuticalindustrystandards.
• Maintainaccurate,complete, andtraceablelaboratorydocumentation,includingsupport for SOPdevelopmentand revision.
• Support deviationinvestigations,changecontrols,CAPAs, auditreadinessactivities, andparticipateinregulatoryinspectionsandclientaudits asrequired.
• Support thetrainingandqualificationoflaboratorycolleaguesandcontributetoknowledgesharingacrossthe team.

WhoweAreLookingFor

Weareseekingahands-onlaboratoryprofessional with astronganalyticalmindset andexperienceworkingwithinaregulatedpharmaceuticalorbiotechenvironment.

Qualifications

• Degreeas aBiomedicalLaboratoryScientist, LaboratoryTechnologist, Research LaboratoryTechnician, orequivalentscientificqualification.
• Minimum 2-5yearsofexperiencein thepharmaceutical,biotechnology, CRO, orregulatedlaboratoryindustry.
• Practicalexperienceperformingbioanalyticaltestingin aGxP-regulatedenvironment.
• Hands-onexperiencewith ELISAassaysisrequired.
• Strongunderstandingoflaboratorydocumentationpractices, dataintegrity, and compliancerequirements.
• ExperiencefollowingandworkingaccordingtoSOPs,validationprotocols, andqualitymanagement systems.
• Fluentin Danish and English,bothwrittenandspoken.

Tosucceedinthisrole,youare:

• Detail-orientedandquality-focused.
• Comfortableperformingrepetitiveanalyticalworkwhilemaintainingaccuracyandconsistency.
• Structuredanddisciplinedinyourdocumentationpractices.
• Proactiveandabletoworkindependentlywithinestablishedprocedures.
• Acollaborativeteam playerwhoenjoysworkingin an internationallaboratoryenvironment.

WhatUnilabs Offers

Anexcitingopportunitytoworkonpharmaceuticaldevelopmentprojectswithdirectimpacton patientcare.

Amodernlaboratoryenvironmentin central Copenhagen.

Strongfocusonscientificdevelopmentand professionalgrowth.

Acollaborativeteamculturewithexperiencedcolleaguesand a highleveloftechnicalexpertise.

Theopportunitytoworkwithadvancedbioanalyticalmethodsin aregulatedsetting.

Thisrolewillparticularlysuitcandidateswhoenjoyspendingthemajorityoftheirtimeconductinglaboratoryanalyses andgeneratinghigh-qualitydata,whilealsocontributingtovalidation, compliance,documentation, andcontinuousimprovementactivities.