Director, Operations - API

Merck; Elkton (VA); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical/dental/vision benefits

401(k) plan

Job summary

Merck is seeking a Director, IPT Leader for API at Elkton, VA to shape the future operating model and drive site readiness for a growing small molecule facility. You will lead strategic planning, cross-functional coordination, and a high-performing IPT to ensure safety, quality, and on-time delivery.

The role requires 10+ years in regulated manufacturing with strong cGMP knowledge, Lean Six Sigma, and financial stewardship.

Qualifications

• Bachelor’s degree or higher in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Engineering, or related discipline.
• Demonstrated experience in pharmaceutical or regulated manufacturing environments.
• 10+ years of relevant experience with leadership experience across Manufacturing/Engineering/Quality/Operations.
• Strong knowledge of cGMP, quality systems, regulatory readiness and safety practices.

Responsibilities

• Lead Site Leadership Team to align IPT priorities with site and company strategy.
• Develop future-state operating model for API operations at Elkton, VA.
• Oversee site ramp-up, startup readiness, and cross-functional coordination.
• Drive safe, compliant, reliable API operations and delivery performance.
• Champion lean thinking and continuous improvement for flow and right-first-time performance.
• Manage budget planning, financial stewardship, and resource allocation.

Skills

Adaptability

API Manufacturing

Biopharma Industry

Lean Six Sigma

Project Leadership

Regulatory Compliance

Data Analysis

Decision Making

Financial Budgeting

Manufacturing Planning

Education

Bachelor’s degree in relevant field

Tools

Lean Six Sigma Certification

Job description

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.

Job Purpose

The Director, IPT Leader, API provides leadership, technical and operational expertise to the Integrated Process Team (IPT) supporting the API manufacturing value stream at the Elkton, VA site. This role is accountable for shaping the future operating model for our 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

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.

Job Purpose

In the early project phases, the incumbent will lead strategic and tactical planning, cross-functional coordination, and project management activities required to support successful site build-out and operational ramp-up. As the site matures, the role will transition into full IPT leadership, accountable for safe, compliant, reliable, and efficient API operations, delivery performance, continuous improvement, stewardship, and people development. The incumbent serves as a member of the site leadership team and ensures alignment of site priorities with divisional and company strategies.

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 API 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 the API operations 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, and reliable and RFT API 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.

Minimum Required Education, Experience

• Bachelor’s degree required. Chemistry, Chemical Engineering, Pharmaceutical Sciences, Engineering, or a related scientific/technical discipline is preferred.
• 10+ years of relevant experience in pharmaceutical or other regulated manufacturing environments.
• Leadership experience in one or more of the following areas: 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.

Preferred Qualifications

• 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.

This is a unique opportunity to help define and lead the future of a growing API site from the ground up. You’ll have the chance to influence how the site operates, build a strong team, and contribute to the delivery of high-quality medicines for patients around the world.

If you are a strategic leader with deep operational experience, a passion for developing teams, and a strong commitment to quality and excellence.

#ELKVACOE

Required Skills

Adaptability, Adaptability, API Manufacturing, Biopharmaceutical Industry, Business Acumen, Business Agility, Capacity Planning, Capital Planning, Data Analysis, Decision Making, Financial Budgeting, Lean Manufacturing, Manufacturing Quality Control, Operational Excellence, Organizational Culture, People Leadership, Plant Turnaround, Process Optimization, Production Management, Production Scheduling, Project Leadership, Project Management, Regulatory Compliance, Results-Oriented, Six Sigma {+ 3 more}

The salary range for this role is

$173,200.00 - $272,600.00

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.

Requirements

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.