Associate Director, Operations — GMP Biotech Start-Up

Merck & Co.; Durham (NC); On-site; USD 129,000 - 203,000; Full time

Job summary

Merck & Co. is seeking an Associate Director of Operations for a capital project start-up in Durham, North Carolina. The role oversees a portion of the manufacturing team across drug substance and product processes, coordinating safety, quality, and project execution.

The position focuses on building the team, aligning with stakeholders, and driving start-up activities for a complex manufacturing facility. The candidate will lead managers and technicians, direct process improvements, and serve

Qualifications

• Bachelor's degree + 8+ years in manufacturing/pharma/vaccines.
• Master's degree + 6+ years in manufacturing/pharma/vaccines.
• Demonstrated leadership of teams or projects.
• Strong communication and regulatory inspection experience.

Responsibilities

• Hire, coach, and develop a team of managers and technicians.
• Ensure execution to schedule and ownership for projects.
• Develop a strong safety culture and site strategy.
• Provide technical SME support during inspections and audits.
• Guide daily production, deviations, and changes.
• Contribute to facility leadership and budget-aligned plans.

Skills

Aseptic Operations

Biopharmaceutical Industry

Capital Projects

Manufacturing Operations

Regulatory Compliance

Strategic Thinking

Team Leadership

Communication Skills

Education

Bachelor's degree in Engineering/Science

Master's degree

Job description

Merck & Co. is seeking an Associate Director of Operations for a capital project start-up in Durham, North Carolina. The role oversees a portion of the manufacturing team across drug substance and product processes, coordinating safety, quality, and project execution.

The position focuses on building the team, aligning with stakeholders, and driving start-up activities for a complex manufacturing facility. The candidate will lead managers and technicians, direct process improvements, and serve