Associate Director – Large Molecule External Manufacturing Technology, Network & Viral Lead

MSD

. Lead the large molecule drug substance portfolio across the global CMO network, primarily supporting commercial technology .

Posted 9/29/2026full-timeUnited StatesSenior💰 $142,400 - $224,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in large molecule drug substance development, including viral vaccines and monoclonal antibodies, while effectively managing cross-functional teams and supplier relationships. Proficient in process transfer, troubleshooting, and commercialization within a global CMO network.

Highest-signal resume keywords

Large Molecule Process DevelopmentViral Vaccine DevelopmentSupplier Technical ManagementCross-Functional Team LeadershipRegulatory Strategy and Execution

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process TransferTroubleshootingCommercializationTechnical TransferManufacturing Process AssessmentProcess ImprovementProject SchedulingSupplier InnovationBiotechnology Product SupplyScale-Up Risk Mitigation

Soft Skills

Strong Business AcumenCommunication SkillsInterpersonal SkillsCollaborationLeadership Attributes

Tools & Technologies

Microsoft PowerPointMicrosoft ProjectPrimaveraSoftware Systems for Supplier Communication

Certifications & Qualifications

Six Sigma CertificationPMP Certification

Industry Keywords

Large Molecule Drug SubstancesMonoclonal AntibodiesVaccine AntigensAntibody Drug ConjugatesMRNAGlobal CMOEU Regulatory StrategyUS Regulatory StrategyFDAUSDA

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Lead the large molecule drug substance portfolio across the global CMO network, primarily supporting commercial technology
Lead or technically lead process transfer and/or development, scale-up, full-scale production, and commercial lifecycle management
Manage sourcing, technical transfer, R&D, process improvement and innovation, and troubleshooting projects, with a focus on viral product network transfers
Conduct spot audits and provide sourcing support
Lead end-to-end execution after supplier selection, managing internal drug product customers and external suppliers
Lead Supplier Technical Management for assigned suppliers and selected drug substances
Lead cross-functional supplier meetings and track changes, deviations, and improvement projects
Lead process change teams with formulation facilities, regulatory, and quality functions
Follow up on deviations and ensure timely, appropriate resolution
Ensure drug substance technology knowledge management
Develop supplier innovation projects to improve process efficiency and reduce cost of goods
Guide supplier process development for R&D projects
Use software systems for supplier communication and change control
Create project schedules with regulatory, formulation, supply chain, quality, procurement, and R&D input
Assess manufacturing processes and equipment and mitigate scale-up, transfer, and process-change risks
Present status updates in governance forums using Microsoft PowerPoint
Assist supplier troubleshooting communications and conduct facility due diligence visits
Partner with Network, Global Procurement, Science & Technology, Quality Assurance, and site manufacturing teams

Requirements

What you’ll need

Bachelor's degree in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable
Minimum 10 years of relevant experience
Experience in development of viral vaccines and a wide array of large molecule drug substances, including monoclonal antibodies, vaccine antigens, antibody drug conjugates, and mRNA
Minimum 5 years in large molecule process development roles
Strong business acumen and communication skills
Proven track record managing sourcing, process development and commercialization, tech transfer, manufacturing process troubleshooting, and biotechnology product supply projects
Strong leadership attributes and global mindset
Demonstrated ability to lead cross-functional teams with an end-to-end supply chain view
Ability to collaborate across functions and geographies and support global activities
Strong interpersonal and communication skills
Ability to maintain relationships with technical, quality, and operations leaders
Proficiency with Microsoft suite applications and scheduling tools such as Microsoft Project and Primavera
Ability to act independently and travel as needed
Preferred: PhD with minimum 7 years of relevant experience
Preferred: Deep understanding of process scale-up for large molecule drug substances
Preferred: Expertise in upstream and downstream troubleshooting
Preferred: Experience managing technical projects in global CMOs
Preferred: Experience conducting CMO due diligence audits
Preferred: Working knowledge of EU and US regulatory strategy and execution, including FDA and/or USDA
Six Sigma and/or PMP certification preferred
Travel required: 15–20%; posting also states travel requirements of 25%
Valid driving license required
No visa sponsorship

Benefits

Comp & perks

Annual bonus and long-term incentive, if applicable
Medical, dental, vision healthcare and other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Hybrid work arrangement