Biologics DCT Lead - Strategy & Launch Excellence

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

Job summary

Merck is seeking a senior leader to head the Development and Commercialization Team (DCT) responsible for delivering a stage-appropriate CMC development and commercialization strategy for the biologics portfolio. The role emphasizes end-to-end execution, robust processes, and a strong governance mindset.

The candidate will drive risk-informed decisions, collaborate across DS/DP/Regulatory/Quality and Supply Chain, and ensure cGMP compliance while balancing speed, cost, and robustness to deliver

Qualifications

• Strong cross divisional networking and leadership across DS/DP/Regulatory/QA/Supply.
• Proven ability to influence at all levels and manage multiple programs.
• Experience with product development, regulatory strategy, and commercialization.
• Ability to navigate ambiguity and drive end-to-end delivery.

Responsibilities

• Lead Development, Chemistry, Manufacturing and Controls (CMC) strategy from development to commercial manufacturing.
• Oversee risk assessment, governance, and option analyses for product strategy.
• Ensure cGMP compliance and maintain robust supply chain and tech transfer.
• Communicate decisions across governance bodies and key stakeholders.

Skills

Cross-functional leadership

Strategic thinking

Problem solving

Communication

Collaboration

Ownership and accountability

Influence

Product management systems

Education

BS degree in engineering or science

MS degree in engineering or science

PhD in engineering or science

Job description

Merck is seeking a senior leader to head the Development and Commercialization Team (DCT) responsible for delivering a stage-appropriate CMC development and commercialization strategy for the biologics portfolio. The role emphasizes end-to-end execution, robust processes, and a strong governance mindset.

The candidate will drive risk-informed decisions, collaborate across DS/DP/Regulatory/Quality and Supply Chain, and ensure cGMP compliance while balancing speed, cost, and robustness to deliver