Director, Operations - Pharm Ops

MSD Malaysia; Elkton (VA); On-site; USD 173,200 - 272,600; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical benefits

401(k) plan

Job summary

MSD Malaysia is seeking a Director of Integrated Process Team (IPT) leadership for the Elkton, VA site to shape the future operating model for the small molecule pharmaceutical manufacturing facility. You will lead strategic planning, cross-functional coordination, and project management to support site build-out and operational ramp-up.

The role requires 10+ years in regulated manufacturing, strong cGMP knowledge, and demonstrated leadership across manufacturing/engineering functions.

Qualifications

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Engineering, or related scientific/technical discipline.
• 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.

Responsibilities

• Site Leadership and Strategy: Lead IPT priorities aligning with site and company strategy and drive tactical/strategic planning for ramp-up and long-term success.
• Future-State Operating Model and Ramp-Up: Develop future-state operating model, support site start-up, ramp-up and readiness activities.
• Operations Excellence and Delivery: Ensure safe, compliant, reliable operations; drive performance reviews, trend analysis, and lean improvements.
• Financial Stewardship: Assist with budget planning and identify productivity and cost-improvement opportunities.
• Quality and Safety Stewardship: Promote a strong quality culture, ensure cGMP compliance, manage deviations and investigations.
• People Leadership: Build and develop a high-performing IPT, promote accountability and ongoing skill-building.

Skills

Leadership

Strategy development

Cross-functional coordination

Project management

Lean Six Sigma

Communication skills

Change leadership

Education

Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Engineering, or related field

Master’s degree (preferred)

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.

Reports To: Site Ops Lead

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 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. 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 pharmaceutical 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 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.

Minimum Required Education, Experience

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Engineering, or a related scientific/technical discipline.
• 10+ years of relevant experience in pharmaceutical, biotechnology 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 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.

Compensation and Benefits

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, and other insurance benefits for employee and family, retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

EEO Statement

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: EEOC Know Your Rights EEOC GINA Supplement.