Director, Biologics Development and Commercialization Team Lead (CMC Team Lead)

Director-level role leading the Development and Commercialization Team for biologics at Merck. Responsible for end-to-end CMC strategy execution, process development, regulatory filings, and commercial manufacturing readiness across multiple sites.

Responsibilities

• Lead Development and Commercialization Team to deliver robust processes, analytics, control strategies, and tech transfer packages
• Oversee on-time execution of CMC deliverables including regulatory filings, approvals, and long-term commercial supply chain
• Identify, prioritize, and mitigate technical, operational, and regulatory risks impacting product success and timelines
• Represent CMC interests across governance bodies and drive outcomes through influence and stakeholder negotiation
• Ensure cGMP compliance and foster a safe, compliant, and collaborative team culture

Requirements

• Demonstrated expertise across drug substance, drug product, device, packaging, and analytical development through commercial launch
• Deep technical leadership in at least one CMC function with recognized scientific credibility
• Understanding of clinical, CMC, and commercial interconnections for product launches
• Strategic thinking with ability to balance speed, cost, and robustness in decision-making
• Experience leading cross-functional teams and influencing stakeholders across governance structures
• Proficiency in cGMP, regulatory requirements, and risk-based decision-making
• Proven ability to navigate ambiguity and develop innovative solutions to complex technical problems