Director, Operations - API
MSD Malaysia
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Job summary
MSD Malaysia's Elkton, VA API leadership role seeks a Director, IPT Leader to shape the future-state operating model for small‑molecule API manufacturing, oversee site readiness, governance, culture, and performance standards.
The role leads cross‑functional planning and execution during build and ramp‑up, ensures cGMP compliance, drives lean improvements, and develops talent to sustain safe, reliable operations and growth.
Qualifications
- Bachelor’s degree in a scientific/technical discipline required.
- 10+ years of relevant pharmaceutical or regulated manufacturing experience.
- Leadership experience across Manufacturing, Technical Operations, Quality, Engineering, or Production Planning.
- Experience leading teams and managing budgets and resources.
- Strong knowledge of cGMP, quality systems, regulatory readiness, and safety practices.
Responsibilities
- Lead Site Leadership Team alignment of IPT priorities with site strategy.
- Develop and implement future-state operating model for Elkton API operations.
- Oversee ramp-up, startup activities, and readiness plans with cross-functional teams.
- Ensure safe, compliant, and reliable API operations with performance metrics.
- Drive lean improvements, capacity and capital planning, and S&OP processes.
Skills
Education
Job description
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. The role is accountable for shaping the operating model of the 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. The incumbent leads strategic and tactical planning, cross‑functional coordination, and project management activities during site build‑out and ramp‑up, and transitions into full IPT leadership to ensure safe, compliant, and efficient API operations as the site matures.
- Serve as a member of the Site Leadership Team and 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.
- Lead the development of the future‑state operating model for API operations at Elkton, VA.
- Support start‑up, ramp‑up, and operational readiness activities through project leadership and cross‑functional coordination.
- Help define organizational structure, culture, operating rhythms, governance, and capability needs.
- Ensure readiness plans, risk assessments, and implementation plans are developed and executed effectively.
- Ensure safe, compliant, and reliable API operations in support of production and supply objectives.
- Lead operational reviews and daily management routines to maintain visibility into performance, issues, and priorities.
- Drive structured problem solving and use 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 enhance flow, throughput, right‑first‑time performance, and operational stability.
- 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.
- Promote a strong quality culture and support a permanent inspection readiness state.
- 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.
- Champion a strong safety culture and support risk‑management activities across the IPT.
- 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.
- Bachelor’s degree in Chemistry, Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a related scientific/technical discipline.
- 10+ 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/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 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.
- 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
- Advanced analytical and problem‑solving abilities.
- Strong stakeholder‑management and communication skills.
- Experience with global manufacturing processes and cross‑regional teams.
- Continuous improvement mindset and a track record of implementing Lean initiatives.
We are an Equal Employment Opportunity Employer. All qualified applicants shall receive equal consideration for employment, regardless of race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status, disability status, or any other legally protected characteristic. We prohibit discrimination in all employment decisions and comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about your rights under U.S. Equal Opportunity Employment laws, visit EEOC: https://www.eeoc.gov.
Salary range: $173,200.00–$272,600.00. Eligible for an annual bonus and long‑term incentive, if applicable. The benefits package includes medical, dental, vision, 401(k) retirement, paid holidays, vacation, compassionate and sick days, and other comprehensive healthcare options.
08/21/2026
10% travel.
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