Director, Technical Operations (Small Molecule Drug Substance)

Merck; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Merck in the United States seeks a transformative leader for Technical Operations in small molecule drug substance. The role combines deep technical operations expertise with team building, regulatory readiness, and continuous improvement to ensure safe, compliant, and reliable supply.

You will lead technology transfer, scale-up, and risk management across the product lifecycle, partnering across Science & Technology, Operations, Quality, and Regulatory to deliver right-first-time execution at a

Job description

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.

At our site, you'll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

The Director and Technical Operations Leader must bring deep and exceptional expertise in Small Molecule Drug Substance technical operations, including strong understanding of manufacturing processes, equipment, process engineering, scale-up, validation, and troubleshooting, as well as the facility systems and their intersections with specific product and process requirements. The individual should have broad experience across the product lifecycle, including tech transfer, continued process verification, and lifecycle management, enabling sound judgment and confident decision‑making in a highly regulated environment.

The ideal candidate will demonstrate strong leadership and cross‑functional collaboration across Science and Technology, Operations, Quality, Supply Chain, and Regulatory functions. They must have the technical operations depth and leadership capability to drive right‑first‑time execution, support deviation reduction, root cause analysis, CAPA effectiveness, and reliability improvements while ensuring stable, compliant supply and strong site performance.

This role requires a leader who can combine technical operations mastery with the ability to build and lead teams, influence, develop people, and drive decisions that support technical and operational excellence, GMP compliance, regulatory readiness, data integrity, and audit readiness.

Technical Operations Subject Matter Expertise

• Deep expertise in small molecule drug substance manufacturing operations, including equipment, facility and infrastructure systems, site operations, process engineering, scale‑up, validation, and troubleshooting.
• Serves as the site Subject Matter Expert (SME) for equipment and facility‑related technical issues.

Product Introduction, Technology Transfer Leadership and Execution Readiness

• Owns site‑level product introductions and technology transfer strategy and execution, including receiving unit responsibilities for tech transfers.
• Integrates operations with product science to ensure end‑to‑end risk assessment, control strategy alignment, and on‑time, right‑first‑time introductions.
• Ensures execution readiness through strong process stewardship and operational risk management.
• Evaluates scale‑up strategies, process performance robustness, and manufacturability to enable successful site implementation.

Technical Problem Solving and Compliance Leadership

• Demonstrates strong judgment and analytical capability to resolve technical challenges and sustain supply.
• Supports regulatory technical queries impacting the site.
• Operates with a strong GMP, data integrity, and audit readiness mindset.
• Ensures technical decisions support compliant, reliable, and high‑quality supply.
• Acts as an escalation point for complex, multi‑site technical issues.
• Ensure readiness for regulatory inspections and internal audits; provide rapid, authoritative technical responses with defensible evidence packages; uphold data integrity and traceability.

Technical Performance Monitoring, Risk Mitigation, and Continuous Improvement

• Proactively monitor commercial performance to detect trends and drive preventive actions.
• Lead technical risk reviews and implement timely mitigations to sustain and improve product and process performance.
• Interpret technical and operational data to inform prioritization and investment decisions by business leaders.
• Systematically feed production insights back into development and network technology strategies.

People and Transformational Leadership for Technical Operations Excellence

• Build a culture of safety, scientific rigor,