About this role
This role leads technical execution and oversight for external manufacturing of small-molecule drug substance within Merck's external manufacturing network. The Senior Specialist/Manager-level technical lead interfaces with external partners to ensure compliance, successful tech transfers, validation, investigations, and continuous process verification.
Key Responsibilities
- Lead technical interface between technical operations and external partner
- Provide technical leadership for commercialization and manufacture of drug substance
- Execute technical due diligence, tech transfers, and receiving site readiness
- Provide manufacturing process support to resolve production issues and optimize process/capacity
- Review external partner process changes, deviations, and master batch record changes; drive continuous process verification and performance monitoring
Technical Overview
You will manage technical due diligence, tech transfers, validation strategies, and ongoing manufacturing process support for external partner sites. The scope includes reviewing process change requests, deviations, and master batch record changes, and driving continuous process verification and process performance monitoring while aligning to regulatory requirements.
Ideal Candidate
The ideal candidate is a senior manufacturing technical leader with 7+ years of experience in drug substance manufacturing, including process start up, routine manufacturing, and technical transfer. They have led external manufacturing partner interfaces, performed technical due diligence, executed tech transfers and validation strategies, and driven continuous process verification and performance monitoring.
Must-Have Skills
Bachelor's degree in engineeringchemistry sciences or related discipline7 years of relevant work experience in manufacturingprocess start uproutine manufacturingtechnical transferdrug substance manufacturetechnical due diligence assessmentsexecuting technical transfers and receiving site readiness activitiesexecuting validation strategies for new and existing productstechnical review of external partner process change requestscontinuous process verification and process performance monitoring program
Required Skills
External ManufacturingSmall Molecule Drug Substancedrug substance manufacturetechnical leadershiptechnical due diligence assessmentstech transfersreceiving site readiness activitiesvalidation strategiesmanufacturing process supportprocess and capacity optimizationcomplex investigationsexternal partner process change requestsdeviationsmaster batch record changescontinuous process verificationprocess performance monitoringregulatory requirements
Hard Skills
drug substance manufactureprocess start uproutine manufacturingtechnical transfercommercialization and manufacture of drug substancetechnical due diligence assessmentstechnology viability assessmentprocess configuration assessmentadherence to required standardstech transferssite readiness activitiesvalidation strategiesmanufacturing process supportprocess and capacity optimizationcomplex investigationsprocess change requests reviewdeviations managementmaster batch record changes reviewcontinuous process verificationprocess performance monitoring programregulatory requirements understandingrisk managementcontinuous improvementexternal partner performance evaluationexternal quality collaborationexternal manufacturing operations collaborationregulatory collaboration
Soft Skills
technical leadershipprimary interface communicationcross-functional collaborationpartner managementproblem-solvingpro-active risk management mindsetcontinuous improvement mindsetleadershipcollaboration and leadership within the small molecule line of business
Keywords for Your Resume
External ManufacturingSmall Molecule Drug Substancedrug substance manufacturetechnical leadprimary interfacetechnical leadershiptechnical due diligence assessmentstech transfersreceiving site readinessvalidation strategiesmanufacturing process supportprocess and capacity optimizationcomplex investigationsexternal partner process change requestsdeviationsmaster batch record changescontinuous process verificationprocess performance monitoringregulatory requirementsrisk managementcontinuous improvementprocess start uproutine manufacturingtechnical transferBachelor's degree
Deal Breakers
Must have a Bachelor's degree in engineering, chemistry sciences or related discipline, Must have at least 7 years of relevant manufacturing experience (process start up, routine manufacturing and/or technical transfer), Must have experience in drug substance manufacture (minimum 5 years explicitly referenced but truncated)
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