✦ Luna Orbit — Engineering (Non-Software)

Assoc. Dir., Engineering

at Merck

📍 2 Locations Hybrid Posted March 13, 2026
Type Not Specified
Experience lead
Exp. Years Not specified
Education Not specified
Category Engineering (Non-Software)

This role leads the technical operations for ADC drug substance manufacturing within Merck’s Large Molecule Technical Operations Unit, focusing on external manufacturing, process validation, and regulatory compliance.

  • Lead external manufacturing collaborations
  • Support tech transfers and validation
  • Assess partner viability and risks
  • Drive process improvements
  • Ensure regulatory compliance

The position involves overseeing bioconjugation processes, manufacturing operations, validation, and external partner collaboration in a regulated biopharmaceutical environment.

The ideal candidate is a senior-level engineer with extensive experience in large molecule biopharmaceutical manufacturing, particularly ADCs. They possess strong leadership skills, regulatory knowledge, and expertise in process validation and external partner management.

Technical leadershipManufacturing process supportExternal partner managementRisk assessmentRegulatory understanding
BioconjugationLarge Molecule ManufacturingQuality SystemsValidation Execution
Regulatory StandardsValidation ToolsManufacturing Systems
Technical leadershipManufacturing supportExternal partner managementRisk assessmentValidationProcess developmentRegulatory complianceDeviation managementProcess optimizationValidation strategies
BiologicalChemicalAutomationCapital ProjectsMaintenanceSafetyProcess DevelopmentTechnical ServicesUtilitiesValidationTech TransfersManufacturingRegulatoryRisk AssessmentProcess OptimizationValidation StrategiesExternal ManufacturingProcess Change ManagementDeviation ManagementInvestigation ManagementContinuous Process VerificationProcess Performance Monitoring
LeadershipCollaborationTechnical GuidanceProblem-solvingCommunication
Industry Healthcare & Medical
Job Function Lead technical operations for ADC manufacturing and external partner management
Technical OperationsTech TransfersADCBioconjugationManufacturingExternal ManufacturingProcess DevelopmentValidationDeviation ManagementRisk AssessmentProcess OptimizationRegulatoryValidation StrategiesManufacturing OperationsLarge MoleculeTechnical leadershipADC drug substanceExternal manufacturingTech transfersProcess developmentRisk assessmentDeviation managementProcess optimizationRegulatory compliance

Lack of experience in bioconjugation or ADC manufacturing, No leadership experience in manufacturing, Unfamiliarity with regulatory standards, Inability to manage external partners

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