Director, Technical Operations (Small Molecule Drug Substance)

Merck; Elkton (VA); On-site; USD 180,000 - 240,000; Full time

Job summary

Merck is seeking a Director and Technical Operations Leader to guide small molecule drug substance operations, including process engineering, scale‑up, validation, and tech transfer. The role requires deep GMP knowledge, regulatory readiness, and cross‑functional leadership to ensure safe, compliant, and reliable supply for a high‑stakes biopharmaceutical manufacturing site in the U.S.

The ideal candidate will oversee site operations, drive right‑first‑time execution, and lead improvements

Qualifications

• Bachelor's degree in science or engineering required.
• Advanced degree in chemistry, chemical engineering or related discipline preferred.
• 10+ years in small molecule drug substance process development or manufacturing operations.
• 7+ years with advanced degree; experience in tech transfer, PPQ, scale-up and lifecycle management.

Responsibilities

• Owns site-level product introductions and tech transfer strategy and execution.
• Ensures end-to-end risk assessment, control strategy alignment and on-time introductions.
• Leads corrective actions and continuous improvement across GMP and data integrity.
• Partners with Quality, Regulatory and Supply Chain to ensure compliant, reliable supply.

Skills

Cross-Functional Leadership

Quality Systems

GMP Compliance

Process Safety

Technical Issues

Technology Transfer

Problem Solving

Education

Bachelor's Degree in Science or Engineering

Advanced degree in Chemistry or Chemical Engineering or related

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.

Director and Technical Operations Leader

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.

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.
• Understands and manages the intersection of process, product, equipment, and facility design to ensure robust, reliable performance.
• Connects and harmonizes with the broader technical operations network to align approaches across similar equipment and processes.
• Supports the industrialization of new technologies and scientific advances.

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.
• Ensures readiness for regulatory inspections and internal audits; provides rapid, authoritative technical responses with defensible evidence packages; upholds 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, accountability, continuous improvement, inclusive leadership, and team capability development.
• Ensure the site has the right technical competencies through effective workforce planning, succession planning, and capability‑building for critical skills and subject matter expertise.
• Champion business process improvement by defining how work is done, streamlining processes, and integrating digital and data‑enabled methods while maintaining compliance and data integrity.
• Drive mindset and leadership shifts across Technical Operations; partner with Operations and Quality to execute transformation programs and embed new ways of working.
• Sponsor digital and analytics capabilities, such as process data platforms, CPV analytics, and advanced modeling, to improve monitoring and decision‑making.
• Lead portfolio prioritization, resource allocation, and governance to support commercial sustainment.
• Possess strong written and oral communication skills and the ability to drive results through team leadership.

Qualifications

• Bachelor's Degree—preferably in Science or Engineering.
• 10+ years of experience in small molecule drug substance process or product development and/or manufacturing technical operations.
• 7+ years of experience, with advanced degree in Chemistry, Chemical Engineering or related discipline.
• Proven track record in new product introduction, tech transfer, PPQ, commercial scale‑up, process validation, and lifecycle management.
• Knowledge of GMP, ICH guidelines, process safety, and Quality Systems; inspection readiness leadership.
• Strong experience leading complex investigations.
• Evidence of driving organizational transformation: capability building, operating model changes, and cross‑functional alignment.
• Exceptional stakeholder management, communication, and influence skills; ability to lead through ambiguity and across geographies.
• Prior responsibility for site portfolios.

Required Skills

• Business Process Improvements
• Capital Management
• Change Management
• Chemical Process Development
• Cross-Cultural Awareness
• Cross-Functional Leadership
• Decision Making
• External Manufacturing
• GMP Compliance
• Innovation
• Manufacturing Scale Up
• Operational Excellence
• Operation Risk Management
• Process Improvements
• Process Safety
• Results-Oriented
• Risk Assessments
• Stakeholder Communications
• Strategic Thinking
• Succession Planning
• Technical Issues
• Technology Transfer
• Transformational Leadership

United States and Puerto Rico residents only are eligible for this role.

We are an Equal Employment Opportunity Employer and do not discriminate on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics.