Analytical Development Chemist in Hamilton

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 environment, 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.
• ExperienceworkingwithsterileproductsandworkinginaBSL2
• Thispositionrequiresflexibilityinworkscheduletosupporta7-dayworkweekinsupportofmorningtonightshiftsinaproductionenvironment.
• Abilitytolift23kilogramsrequired.

Compensation:

Annual salary starts at $74k.

• GroupHealth&DentalBenefits(fromday1)
• RRSPMatchingProgram
• EmployeeAssistanceandWellnessPrograms

AtomVie does not use artificial intelligence or automated decision-making tools in any part of the recruitment, screening, or selection process.

We are committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.