AAV CMC Consultant (Independent Contractor)

About the company

How Jobgether works We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether?

Your tasks

• AssessCMCreadinessanddefinestrategy:ConductacomprehensiveCMCgapanalysisagainstthetargetproductprofileduringthefirstmonth,identifytechnicalandregulatoryrisks,anddevelopaprioritizedplantoaddressoutstandinggaps.ReviewtheCDMOmasterservicesagreementandinitialprocessdevelopmentandmanufacturingplans,providingpracticalrecommendations.
• LeadCDMOcollaborationandprojectexecution:Establishagendasandleadregulartechnicalworkingmeetings,documentdecisionsandactionitems,assignownersanddeadlines,andfollowupondeliverables.Monitorprogress,resolveissues,escalateriskswhennecessary,andmaintainmomentumagainstprojectmilestones.
• Guideprocessandanalyticaldevelopment:ProvideexpertguidanceonupstreamanddownstreamAAVmanufacturingprocesses,analyticaldevelopment,productcharacterization,andreleasestrategies.Developrecommendationsforaphase-appropriatepotencyassaystrategyandhelpensurethatmanufacturingprocessesandanalyticalmethodsalignwithprogramrequirements.
• Overseemanufacturingreadinessandmaterialdelivery:CoordinatewiththeCDMOtosupportthesuccessfulcompletionofanon-GMPengineeringrunwithintheplannedsix-monthengagement,targetingdeliveryofmaterialfortheGLPtoxicologystudy.Monitormanufacturingtimelines,materialquality,quantity,andreadinessforsubsequentdevelopmentactivities.
• DevelopregulatoryCMCdocumentation:DraftandsubstantiallycontributetoModule3contentforpre-INDandINDsubmissions.PrepareCMCbriefingmaterials,identifydocumentationgaps,andensuretechnicalinformationisclear,consistent,andalignedwiththeprogram'sregulatorystrategy.
• Supportregulatoryinteractions:ServeastheCMCsubject-matterexpertduringFDAmeetings,prepareresponsestotechnicalandmanufacturingquestions,andprovidescientificallysupportedrecommendationstoinformregulatorydiscussionsandnextsteps.
• Managerisksandtechnicaldecisions:Investigatemanufacturingandanalyticalchallengesusingscientificevidence,evaluatealternativeapproaches,andpresentwell-supportedrecommendations.Maintainclearaccountabilityforexternaldeliverableswhileleavingfinalprogramdecisionstotheinternalleadershipteam.

Requirements

• AAVgenetherapyexperience:DemonstratedexperiencetakinganAAVgenetherapyprogramthroughCMCdevelopmenttoafirst-in-humanPhase1clinicaltrial.
• Manufacturingexpertise:Experiencewithtriple-transfectionHEK293suspensionprocessesandastrongunderstandingofAAVmanufacturing,processdevelopment,andproductionconsiderations.
• Regulatorydocumentation:ExperiencewritingorsubstantiallycontributingtoModule3documentationforbothpre-INDandINDapplications,withtheabilitytopreparehigh-qualityCMCbriefingmaterialsandsupportFDAinteractions.
• CDMOandvendormanagement:Provenabilitytomanageexternalmanufacturingpartners,coordinatetechnicalworkstreams,resolveconflicts,trackdeliverables,andholdvendorsaccountableforqualityandtimelines.
• Technicalbreadth:StrongunderstandingofCMCactivities,includingupstreamanddownstreamprocessdevelopment,analyticaldevelopment,drugsubstance,drugproduct,releasetesting,andmanufacturingsupplychains.
• Scientificandanalyticaljudgment:Abilitytoinvestigatecomplextechnicalquestions,evaluateevidence,identifyrisks,anddeveloppractical,scientificallyjustifiedrecommendations.
• Projectmanagement:Excellentorganizationalandcommunicationskills,withtheabilitytoleadproductivemeetings,establishclearactionplans,managecompetingpriorities,anddeliveragainstaggressivemilestones.
• Independentconsultingcapability:Comfortableworkingautonomously,managingadefinedscopeofwork,andcollaboratingeffectivelywithinternalstakeholdersandexternalpartnersinaremoteenvironment.
• Preferredqualifications:DirectAAVCDMOmanagementexperience;multiplesuccessfulINDsubmissionsandGMPmanufacturingbatches;GLP/GMPanalyticaldevelopmentexperience;experienceadvancingAAVprogramsintolater-stageclinicaltrialsorcommercialization;knowledgeoflarge-animalIND-enablingandtoxicologystudies;andstrongregulatoryjudgment.

What we offer

• Competitive consulting engagement: Independent contractor arrangement with compensation and scope defined in a consulting agreement and Statement of Work.
• Flexible working hours: Approximately 20–40 hours per week, depending on the project phase, with scheduling flexibility around CDMO meetings and critical milestones.
• Remote work: Work remotely from the United States, with occasional travel for key project presentations and manufacturing activities.
• Travel expenses covered: Business travel to the project headquarters and the CDMO will be reimbursed.
• Independent consulting flexibility: Continue working with other clients, subject to applicable conflict-of-interest restrictions.
• High-impact scientific contribution: Help advance an innovative AAV gene therapy program toward clinical development and contribute to establishing a CMC strategy for a potentially transformative treatment.
• Defined project duration: Approximately six months, with an anticipated start in December 2026.
• Application deadline: October 30, 2026, with applications reviewed on a rolling basis.

Other

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.