Biologics Development & Commercialization Director

Merck & Co.; West Point (PA); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Merck & Co. in West Point, PA, is seeking a Development and Commercialization Team (DCT) leader to deliver an integrated CMC development and commercialization strategy for the biologics portfolio.

The role emphasizes end-to-end execution, governance influence, and safeguarding high-quality processes across DS, DP, device, packaging, and regulatory domains. The successful candidate will lead risk mitigations, drive technical reviews, and ensure robust transfer packages while aligning with global

Qualifications

• BS/ MS/ PhD in relevant engineering or science fields with significant experience
• Strong cross-divisional networking and leadership capabilities
• Understanding of product management systems and tools, business and financial skills

Responsibilities

• Oversee end-to-end DCT deliverables, ensuring robust processes, analytics, and a seamless tech transfer to commercial supply
• Assess deliverables, mitigate risks across technical, regulatory, and operational factors, and guide governance decisions
• Represent CMC in governance bodies and drive decisions to balance speed, cost, and robustness
• Maintain compliance with cGMP, regulatory requirements, and a culture of safe, compliant operations

Skills

Biologics

Chemical Process Development

CMC Biologics

Collaborative Leadership

Commercialization

Cross-Functional Leadership

Decision Making

New Product Launch

Organizational Leadership

Pharmaceutical Industry

Process Improvements

Product Launches

Results-Oriented

Strategic Thinking

Supply Chain

Team Organization

Technology Transfer

Technical Writing

Education

BS/MS/PhD in relevant field

Job description

Merck & Co. in West Point, PA, is seeking a Development and Commercialization Team (DCT) leader to deliver an integrated CMC development and commercialization strategy for the biologics portfolio.

The role emphasizes end-to-end execution, governance influence, and safeguarding high-quality processes across DS, DP, device, packaging, and regulatory domains. The successful candidate will lead risk mitigations, drive technical reviews, and ensure robust transfer packages while aligning with global