AtomVieGlobalRadiopharmaInc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.

We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.

AbouttheRole

The Analytical Development Chemist will be responsible for working in accordance with company policy and within GMPs, while contributing technical expertise to support current products and develop future drugs within the AtomVie portfolio or through support of our CDMO functions.

This posting is for an existing vacancy to support the expansion of the company.

WhatYouWillDo

- Conductanalyticalmethoddevelopment,transfer,validation,andstabilitytestingactivitiesforvariousanalyticaltechniqueswhichmayincludeChemical,BiologicalandMicrobiologicaltestingmethods.
- Performtestingofdevelopmentdrugproductsandstabilitysamplesusingdraftmethods.
- Writetestreports,datasummaries,technicaldocuments(e.g.,specifications,releasecertificates),andvalidationprotocolswithinputfromSMEs;generatedataevaluationsummariesandstatisticalevaluations.
- Report data in client presentations; attend meetings and present data at client sessions as required.
- Conductroutineandcomplexvalidationactivitiesasperapprovedprotocolsandmethods;writevalidationreportsinlinewithregulatoryguidelines(ICH,USP,etc.).




- Supportqualitycontroltestingoffinisheddrugproductsandproductdevelopmentmaterialrelease;coordinatequalitytestingofexcipients,precursors,anddrugsubstanceswithcontractlaboratoriesorresearchorganizations.
- Performqualityinvestigations,includingnon-conformancesandtestingfailures;writeinvestigationreports(e.g.,INVs,NCs,CAPAs),prepareCAPAimplementationplans,andimplementcorrectiveactions.
- Participateinprocessimprovementinitiatives,includinginitiatingchangecontrols,revisingmethods,andcreatingnewprocedures(e.g.,STMs,SOPs,forms,templates).
- Conductpeerreviewsoflaboratoryrecords,trainingdocuments,andtechnicalreports;traincolleaguesandprovidefeedback.
- Manageinventoryofanalyticalreagents,criticalmaterials,referencestandards,andconsumables;ensurelaboratoryequipmentcalibration,maintenance,andtroubleshootingwithSMEguidance.
- Maintainhousekeepingandhazardouswastedisposal(chemicalandradioactive)incompliancewithAtomVieSOPs;monitorprocedureeffectivenessandproposeimprovements.
- Fulfillregulatorydocumentationrequirements,includingradioactivematerialtransferforms,andensurecompliancewithHealthCanada,FDAGMPregulations,andCanadianNuclearSafetyCommissionguidelines.
- Reportradiologicalcontaminationevents,participateininvestigations,andimplementcorrectiveactions.
- Collaboratewithteammemberstoachieveoutcomesalignedwithproductionandstabilityplans.




- EnsureadherencetoGMPbymaintainingcompleterecordsfortraining,analyticaltesting,routineoperations,andequipmentmaintenance.
- Maintainknowledgeofregulatoryguidance,pharmacopeias,ICH,andapplicablebusinessprotocolsandprocedures.
- Ensurecompliancewithallhealth,safety,andregulatoryrequirementsforworkactivities.
- Plan,implement,andcompletetasksinatimelymannerwithhighquality.
- Completeallotherrelateddutiesasassigned.

WhatYouBringToTheRole

- Experienceinmethoddevelopmentandvalidation,anddocumentationofsuchstudies,isanasset.
- Knowledge of microbiological testing (Bioburden, Sterility, Bacterial Endotoxins) is an asset.
- KnowledgeofUV,IR,massspectrometry,andNMRisanasset.
- Excellentcommunicationskills(inEnglish)andabilitytoworkbothindependentlyandcooperativelyinateamenvironment.
- ProficiencywithequipmentdataprocessingsoftwaresuchasEmpower(WatersHPLC).
- Proficiencywithspreadsheets(e.g.Excel,GoogleSheets),wordprocessingsoftware(e.g.Word)andpresentationsoftware(e.g.,PowerPoint)
- Goodwritingskills:abilitytowritetechnicaldocumentsandreports,andtheabilitytorapidlyinputdataandretrieverecords,statistics,trends,etc.,andtopreparetechnicalrpresentationsforcustomermeetings.

Requirements

- UniversityDegreeinBiology,BiologicalChemistry,Biotechnology,orarelateddiscipline.M.Sc.orPh.Dispreferred.
- 3-4 years of related experience in in a pharmaceutical cGMP setting, performing analytical chemistry techniques such as HPLC, GC and TLC, microbiology tests such as Bacterial Endotoxins, and/or Biology tests such as IRF, ELISA and SDS-PAGE.
- Experience working with small molecules, antibodies, proteins and antibody-drug conjugates, protein characterization, UV/VIS, etc.

📌 Analytical Development Chemist (Canada)
🏢 AtomVie Global Radiopharma
📍 Canada