Biologics Development & Commercialization Director

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

Job summary

Merck & Co., Inc. in the USA—Pennsylvania, West Point, seeks a Development and Commercialization Team (DCT) leader to deliver a fully integrated CMC development and commercialization strategy for the biologics portfolio.

You will lead end-to-end DCT activities, drive robust processes, tech transfer, filing and supply continuity, and influence governance decisions to steer the product to market. This role requires senior leadership, strategic thinking, risk management, and the ability to navigate

Qualifications

• Minimum Educational Requirement: BS with 15 years of relevant experience, or MS with 12 years, or PhD with 10 years.
• Strong cross-divisional networking and enterprise leadership experience.
• Experience governing product management systems, tools, and regulatory knowledge.

Responsibilities

• Lead end-to-end DCT deliverables including robust processes, analytics, control strategy, tech transfer, filing, and supply continuity.
• Assess and mitigate risks across technical, regulatory, and operational factors; influence governance and strategy.
• Communicate effectively across governance bodies and stakeholders; balance speed, cost, and robustness to achieve the target product.
• Drive compliance with cGMP and regulatory requirements; foster a safe and compliant culture.
• Collaborate to ensure best science and robust processes are used, working with DCRC and product teams.

Skills

Biologics

Chemical Process Development

CMC Biologics

Collaborative Leadership

Commercialization

Cross-Functional Leadership

Decision Making

New Product Launch Strategies

Organizational Leadership

Pharmaceutical Industry

Process Improvements

Product Launches

Results-Oriented

Strategic Thinking

Supply Chain

Team Organization

Technology Transfer

Writing Technical Documents

Education

Bachelor of Science in relevant engineering or science fields

Job description

Merck & Co., Inc. in the USA—Pennsylvania, West Point, seeks a Development and Commercialization Team (DCT) leader to deliver a fully integrated CMC development and commercialization strategy for the biologics portfolio.

You will lead end-to-end DCT activities, drive robust processes, tech transfer, filing and supply continuity, and influence governance decisions to steer the product to market. This role requires senior leadership, strategic thinking, risk management, and the ability to navigate