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MSD

Director, Biologics Development – Commercialization Team Lead

MSD

. Deliver a fully integrated, stage-appropriate CMC development and commercialization strategy for the biologics portfolio .

Posted 10/14/2026full-timeUnited StatesSenior💰 $173,200 - $272,600 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in CMC development and commercialization strategies for biologics, with a strong focus on regulatory compliance, technical leadership, and cross-functional collaboration. Proven ability to manage complex programs and drive successful outcomes in product commercialization while maintaining adherence to cGMP standards.

Highest-signal resume keywords
CMC Development StrategyRegulatory ComplianceTechnical LeadershipProduct Management SystemsCross-Divisional Networking

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Biologics CommercializationTechnical Product StewardshipBLA AssemblyAnalytical DevelopmentSupply Chain ManagementQuality AssuranceProcess AnalyticsTechnology TransferRisk MitigationOptions Analysis
Soft Skills
Collaborative SkillsInfluencing SkillsNegotiation SkillsDetail-OrientedLeadership
Tools & Technologies
Product Management ToolsRegulatory SystemsCGMP Compliance Tools
Industry Keywords
Large Molecule ProgramsGlobal Regulatory RequirementsCommercial Supply ChainDevelopment and Commercialization TeamTechnical Reviews

Tech Stack

Tools & technologies
Assembly

About the role

Key responsibilities & impact
  • Deliver a fully integrated, stage-appropriate CMC development and commercialization strategy for the biologics portfolio
  • Execute DCT deliverables end to end, including processes and analytics, integrated control strategy, technology transfer packages, filing and approval, and commercial supply chain
  • Lead the Development and Commercialization Team and assess team deliverables
  • Foster a learning, collaborative, safe, and compliant environment
  • Prioritize, interrogate, and mitigate technical, operational, and regulatory risks
  • Develop innovative solutions to unforeseen circumstances
  • Own product technical processes and associated technical challenges
  • Conduct options analysis and provide recommendations to governance
  • Represent CMC across governance bodies, stakeholders, and teams
  • Drive decisions and outcomes through influence, advocacy, and negotiation
  • Challenge product development strategy to ensure a robust CMC strategy
  • Balance speed, cost, and robustness to achieve the target commercial product
  • Direct technical reviews and ensure robust solutions are developed by supporting working teams
  • Maintain compliance with company global and regulatory requirements and cGMP

Requirements

What you’ll need
  • Bachelor of Science (BS) degree in a relevant engineering or science field with fifteen (15) years of relevant experience, or Master of Science (MS) degree with twelve (12) years of relevant experience, or PhD with ten (10) years of relevant experience
  • Strong cross-divisional networking skills and capabilities
  • Demonstrated functional and enterprise leadership, with ability to influence at all levels of the organization
  • Strong collaborative skills and ability to work strategically and in a detail-oriented framework with all levels of management
  • Strong understanding of product management systems and tools
  • Strong business and financial skills
  • Ability to manage multiple programs and create a high-performance work environment
  • Experience in technical product stewardship
  • Demonstrated track record of successfully commercializing multiple large molecule programs across a variety of platforms
  • Expert knowledge in global regulatory requirements for large molecule commercialization and BLA assembly
  • Expertise across DS, DP, Device, Packaging, Analytical, Regulatory, Quality, and Supply Chain from early development through commercial manufacturing
  • Recognized technical leadership and scientific excellence in at least one CMC function
  • Must comply with global and regulatory requirements and execute current Good Manufacturing Practices (cGMP)
  • No visa sponsorship available
  • US and Puerto Rico residents only

Benefits

Comp & perks
  • Annual bonus
  • Long-term incentive, if applicable
  • Medical, dental, and vision healthcare
  • Other insurance benefits for employee and family
  • Retirement benefits, including 401(k)
  • Paid holidays
  • Vacation
  • Compassionate days
  • Sick days
  • Hybrid work arrangement
  • 10% travel requirement