Technical Operations Lead, Strategy & Execution

MSD Malaysia; Durham, Northern (NC, KY); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision benefits

Paid holidays and generous PTO

Job summary

Merck & Co., Inc. in the United States is seeking a senior leader to direct technical operations for drug substance development and manufacturing. You will oversee a multi-disciplinary team of engineers and scientists, drive strategy for process development, and ensure robust quality and regulatory compliance across the project lifecycle.

The role emphasizes aseptic processing, GMP standards, and cross-functional collaboration to achieve milestones and deliver safe, effective biologics at scale.

Qualifications

• Bachelor’s, Master’s, or Doctorate in chemical/biochemical engineering or related discipline.
• 4–7+ years in pharmaceutical operations, technical services, or quality operations with people management.
• Strong decision-making, problem-solving, and communication skills.
• Aseptic manufacturing and GMP experience, ideally with biological drug substance.

Responsibilities

• Lead strategy development and manage project assignments.
• Direct a team of engineers and scientists supporting drug substance tech transfer.
• Provide end-to-end technical support across project lifecycles and QA activities.
• Lead cross‑functional teams to meet milestones and review critical documents.
• Support quality risk assessments and regulatory inspections; promote safety and compliance.

Skills

API Manufacturing

Aseptic Processing

Biologics

Change Control

Chemical Process Development

Cross‑Cultural Awareness

Cross‑Functional Teamwork

Equipment Qualification

Manufacturing Process Validation

People Leadership

Process Optimization

Regulatory Inspections

Regulatory Requirements

Results‑Oriented

Strategic Thinking

Technical Guidance

Technology Transfer

Education

Bachelor’s/Master’s/Doctorate in chemical engineering or related life science

Tools

Lean/Six Sigma

Job description

Merck & Co., Inc. in the United States is seeking a senior leader to direct technical operations for drug substance development and manufacturing. You will oversee a multi-disciplinary team of engineers and scientists, drive strategy for process development, and ensure robust quality and regulatory compliance across the project lifecycle.

The role emphasizes aseptic processing, GMP standards, and cross-functional collaboration to achieve milestones and deliver safe, effective biologics at scale.