Director, Biologics Development and Commercialization Team Lead (CMC Team Lead)
Merck
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
Vacancy posted 2 days ago
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