Director, Operations - Pharm Ops
Merck
Summary
The Director, IPT Leader, Pharm Ops provides leadership, technical and operational expertise to the Integrated Process Team (IPT) supporting the Pharmaceutical Operations manufacturing value stream at the Elkton, VA site. This role is accountable for shaping the future operating model for a new small molecule pharmaceutical manufacturing facility, including project and site readiness, organizational design, and the establishment of operating rhythms, governance, IPT culture, Ways of Working, and performance standards.
Job description
Job Purpose
The Director, IPT Leader, Pharm Ops provides leadership, technical and operational expertise to the Integrated Process Team (IPT) supporting the Pharmaceutical Operations manufacturing value stream at the Elkton, VA site. This role is accountable for shaping the future operating model for a new small molecule pharmaceutical manufacturing facility, including project and site readiness, organizational design, and the establishment of operating rhythms, governance, IPT culture, Ways of Working, and performance standards.
Primary Responsibilities
Site Leadership and Strategy
- Serve as a member of the Site Leadership Team and help align IPT priorities with site and company strategy.
- Provide direction to establish tactical and strategic plans that support Pharm Ops ramp-up and long-term operational success.
- Partner across the site and with above-site teams to ensure strong coordination, decision-making, and execution.
- Represent the IPT and the site as needed with internal stakeholders and external partners.
Future-State Operating Model and Ramp-Up
- Lead the development of the future-state operating model for Pharm Ops at Elkton, VA.
- Support site start-up, ramp-up, and operational readiness activities through project leadership and cross-functional coordination.
- Help define organizational structure, organizational culture, operating rhythms, governance, and capability needs for the evolving site.
- Ensure readiness plans, risk assessments, and implementation plans are developed and executed effectively.
Operations Excellence and Delivery
- Ensure safe, compliant, reliable, and right-first-time pharmaceutical operations in support of production and supply objectives.
- Lead operational reviews and daily management routines to maintain visibility to performance, issues, and priorities.
- Drive structured problem solving and the use of performance metrics to identify trends, action plans, and opportunities for improvement.
- Support production planning, resource deployment, and issue resolution to meet site objectives.
- Promote lean thinking and continuous improvement to improve flow, throughput, right-first-time performance, and operational stability.
Financial Stewardship
- Support and/or own budget planning and financial stewardship for the IPT, including operating and capital spend.
- Partner with site leadership to identify opportunities for productivity, efficiency, and cost improvement.
- Ensure resources are allocated effectively to support current and future business needs.
Quality and Safety Stewardship
- Promote a strong quality culture and support a state of permanent inspection readiness.
- Ensure cGMP compliance and effective management of deviations, investigations, and corrective actions.
- Partner with Quality, EHS, Engineering, Technical, and Supply Chain teams to support site priorities and maintain strong compliance standards.
- Ensure appropriate training, documentation, and change management practices are in place to support safe and compliant operations.
- Champion a strong safety culture and support risk management activities across the IPT.
People Leadership
- Lead, coach, and develop a team of leaders and contributors to build a high-performing organization.
- Foster a culture of accountability, collaboration, empowerment, and continuous learning.
- Support talent development, succession planning, and ongoing skill-building within the IPT.
- Communicate clearly and regularly to align the team around priorities, expectations, and performance.
Requirements
- Bachelor's degree required
- Chemistry, Chemical Engineering, Pharmaceutical Sciences, Engineering, or related scientific/technical discipline preferred
- 10+ years of relevant experience in pharmaceutical, biotechnology or other regulated manufacturing environments
- Leadership experience in Manufacturing, Technical Operations, Quality Operations, Engineering, and/or Production Planning
- Experience leading teams with direct and indirect reports
- Strong knowledge of cGMP, quality systems, regulatory readiness, and safety/environmental practices
- Demonstrated experience with operational planning, project leadership, or site ramp-up/start-up activities
- Proven ability to lead in complex environments and manage multiple priorities across functions
- Strong business acumen and experience with financial stewardship and resource planning
- Experience applying Lean Six Sigma, continuous improvement, and structured problem-solving tools
- Effective communication, coaching, and change leadership skills
- Master's degree in Science, Engineering, Business, or related discipline preferred
- Experience in small molecule pharmaceutical manufacturing or oral solid dose operations preferred
- Prior experience supporting a manufacturing site start-up, transformation, or ramp-up preferred
- Experience developing future-state operating models, organizational structures, or operational governance systems preferred
- Lean Six Sigma certification or deep practical application of Lean tools preferred
- Experience in a highly matrixed global manufacturing environment preferred
- Demonstrated success in talent development, employee engagement, and succession planning preferred
- Experience with capacity planning, capital planning, supply planning, and S&OP preferred
- Familiarity with inspection readiness, deviation management, and broader quality systems in a regulated environment preferred
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Holidays
- Vacation
- Compassionate & Sick Days
- Annual Bonus
- Long-Term Incentive
- Relocation Assistance
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.