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.
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.
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, 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.
#ELKVACOE
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
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
The salary range for this role is $173,200.00 - $272,600.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
