Director, API Operations & Site Ramp-Up

MSD Malaysia

Virginia, Northern (MN, KY)

Hybrid

USD 173,000 - 273,000

Full time

6 days ago
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Benefits offered by this job

Medical benefits
Dental benefits
Vision benefits
401(k)

Job summary

Merck & Co., Inc. seeks a Director, IPT Leader for Elkton, VA, to shape the future operating model of the API site and drive safe, compliant, and efficient manufacturing operations.

You will lead cross-functional teams, coordinate site ramp-up, and establish governance, performance standards, and continuous improvement culture. The role requires 10+ years in pharma manufacturing, strong leadership, Lean Six Sigma, and proven ability to manage complex, matrixed environments while aligning with

Qualifications

  • Minimum 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.
  • 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.
  • Experience applying Lean Six Sigma and structured problem-solving tools.

Responsibilities

  • Lead Site Leadership Team alignment of IPT priorities with site and company strategy.
  • Develop future-state operating model for API operations at Elkton, VA.
  • Ensure safe, compliant, reliable API operations and drive performance metrics and improvements.
  • Oversee budget planning and financial stewardship for the IPT and optimize resources.
  • Promote quality culture, cGMP compliance, deviations, investigations, and CAPAs.
  • Lead, coach, and develop a high-performing IPT team and foster accountability.

Skills

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

Education

Bachelor’s degree in Chemistry, Chemical Engineering, Mechanical Engineering, Electrical Engineering, or related discipline
Master’s degree in Science, Engineering, Business, or related discipline

Job description

Merck & Co., Inc. seeks a Director, IPT Leader for Elkton, VA, to shape the future operating model of the API site and drive safe, compliant, and efficient manufacturing operations.

You will lead cross-functional teams, coordinate site ramp-up, and establish governance, performance standards, and continuous improvement culture. The role requires 10+ years in pharma manufacturing, strong leadership, Lean Six Sigma, and proven ability to manage complex, matrixed environments while aligning with

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