Director, Operations - API

Merck•Elkton, VA

8d•$173,200 - $272,600

About The Position

The Director, IPT Leader, API provides leadership, technical and operational expertise to the Integrated Process Team supporting the API manufacturing value stream at the Elkton, Virginia site. The role is accountable for shaping the operating model for a new small-molecule pharmaceutical manufacturing facility, including project and site readiness, organizational design, operating rhythms, governance, IPT culture, ways of working, and performance standards. During the early project phases, the Director leads strategic and tactical planning, cross-functional coordination, and project management activities that support site build-out and operational ramp-up. As the site matures, the role transitions into full IPT leadership, with accountability for safe, compliant, reliable, and efficient API operations; delivery performance; continuous improvement; stewardship; and people development. The Director is a member of the site leadership team and aligns site priorities with divisional and company strategies.

Requirements

Bachelor’s degree required.
10 or more years of relevant experience in pharmaceutical 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 and environmental practices.
Demonstrated experience with operational planning, project leadership, or site ramp-up/start-up activities.
Ability to lead in complex environments and manage multiple cross-functional priorities.
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.

Nice To Haves

Master’s degree in Science, Engineering, Business, or a related discipline.
Experience in small-molecule API manufacturing or commercial pharmaceutical operations.
Prior experience supporting a manufacturing site start-up, transformation, or ramp-up.
Experience developing future-state operating models, organizational structures, or operational governance systems.
Lean Six Sigma certification or deep practical application of Lean tools.
Experience in a highly matrixed global manufacturing environment.
Demonstrated success in talent development, employee engagement, and succession planning.
Experience with capacity planning, capital planning, supply planning, and S&OP.
Familiarity with inspection readiness, deviation management, and broader quality systems in a regulated environment.
Chemistry, Chemical Engineering, Pharmaceutical Sciences, Engineering, or a related scientific or technical discipline.

Responsibilities

Serve as a member of the Site Leadership Team and align IPT priorities with site and company strategy.
Establish tactical and strategic plans that support API ramp-up and long-term operational success.
Partner across the site and with above-site teams to support coordination, decision-making, and execution.
Represent the IPT and site with internal stakeholders and external partners as needed.
Develop the future-state operating model for API operations at Elkton, Virginia.
Support site start-up, ramp-up, and operational readiness through project leadership and cross-functional coordination.
Define organizational structure, culture, operating rhythms, governance, and capability needs for the evolving site.
Ensure readiness plans, risk assessments, and implementation plans are developed and executed.
Ensure safe, compliant, reliable, and right-first-time API operations in support of production and supply objectives.
Lead operational reviews and daily management routines to maintain visibility into performance, issues, and priorities.
Use structured problem solving and performance metrics to identify trends, action plans, and improvement opportunities.
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.
Support or own IPT budget planning and financial stewardship, including operating and capital spend.
Work with site leadership to identify productivity, efficiency, and cost-improvement opportunities.
Allocate resources effectively to support current and future business needs.
Promote a strong quality culture and support 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 compliance.
Ensure training, documentation, and change-management practices support safe and compliant operations.
Champion safety and support risk-management activities across the IPT.
Lead, coach, and develop leaders and contributors to build a high-performing organization.
Foster accountability, collaboration, empowerment, and continuous learning.
Support talent development, succession planning, and ongoing skill-building within the IPT.
Communicate regularly and clearly to align the team around priorities, expectations, and performance.