Associate Director, Technical Operations | GMP Biologics

Merck; Durham (NC); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co., Inc. seeks an Associate Director, Technical Operations in Durham, NC to lead drug substance manufacturing with end-to-end processing and QA lab oversight. You will guide a team of engineers and scientists during tech transfer, risk assessment, and process development, ensuring GMP compliance.

The role emphasizes strategic leadership, cross-functional collaboration, and a strong quality mindset to support startup operations and regulatory readiness.

Qualifications

• Bachelor’s, Master’s, or Doctorate in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry, or related life science or engineering discipline.
• Minimum of four (4) years (Doctorate), six (6) years (Master's), or seven (7) years (Bachelor’s) experience in pharmaceutical operations, technical services, and/or quality operations including prior people management experience.
• Effective decision-making, problem-solving, and communication skills.
• Ability to manage multiple priorities and complex problems in a fast-paced environment.
• Aseptic manufacturing and GMP manufacturing experience, preferably with biological drug substance.

Responsibilities

• Lead technical operations for drug substance manufacturing within a start-up environment.
• Coach and develop engineers and scientists in drug substance tech transfer.
• Provide end-to-end technical support across project lifecycle, including risk management and SOPs.
• Lead cross-functional teams to address issues and meet milestones.
• Review and approve project documents related to drug substance, utilities, equipment, changes, and CAPAs.
• Serve as SME for quality risk assessments and regulatory inspections.
• Support safety, environmental and compliance objectives.

Skills

API Manufacturing

Aseptic Processing

Biologics

Change Control

Chemical Process Dev

Cross-Cultural Awareness

Cross-Functional Teamwork

Equipment Qualification

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/Biochemical/ Biological Sciences

Job description

Merck & Co., Inc. seeks an Associate Director, Technical Operations in Durham, NC to lead drug substance manufacturing with end-to-end processing and QA lab oversight. You will guide a team of engineers and scientists during tech transfer, risk assessment, and process development, ensuring GMP compliance.

The role emphasizes strategic leadership, cross-functional collaboration, and a strong quality mindset to support startup operations and regulatory readiness.