Director, Operations - Pharm Ops

Merck•Elkton, VA

11d•$173,200 - $272,600•Onsite

About The Position

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, 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 early project phases, the Director leads strategic and tactical planning, cross-functional coordination, and project management for site build-out and operational ramp-up. As the site matures, the role transitions to full IPT leadership, accountable for safe, compliant, reliable, and efficient pharmaceutical operations; delivery performance; continuous improvement; stewardship; and people development. The position 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, 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 and 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 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 pharmaceutical manufacturing or oral solid dose 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 another related scientific/technical discipline is preferred.

Responsibilities

Serve as a member of the Site Leadership Team and align IPT priorities with site and company strategy.
Provide direction for tactical and strategic plans supporting Pharm Ops ramp-up and long-term operational success.
Partner across the site and with above-site teams to coordinate decision-making and execution; represent the IPT and site with internal stakeholders and external partners as needed.
Lead development of the future-state operating model for Pharm Ops at Elkton.
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.
Develop and execute readiness plans, risk assessments, and implementation plans.
Ensure safe, compliant, reliable, and right-first-time pharmaceutical operations that support production and supply objectives.
Lead operational reviews and daily management routines to monitor performance, issues, and priorities.
Use structured problem solving and performance metrics to identify trends, actions, 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, and allocate resources effectively.
Promote a strong quality culture and 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 on site priorities and compliance standards.
Ensure appropriate training, documentation, and change-management practices support safe and compliant operations; champion safety and risk management across the IPT.
Lead, coach, and develop leaders and contributors; foster accountability, collaboration, empowerment, and continuous learning.
Support talent development, succession planning, and skill-building, and communicate priorities, expectations, and performance clearly and regularly.