Director, Biologics Analytics & GMP Operations

Merck; Rahway (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Merck in Rahway, NJ seeks a Director to lead a growing GMP analytical team supporting biologics manufacturing. The role encompasses reliable analytical delivery, people development, and maintaining a rigorous quality culture during expansion into ADC, sterile filling, and monoclonal antibody production.

The candidate will lead batch-release and stability testing, oversee investigations, and partner with cross-functional teams to align testing priorities and risk management.

Qualifications

• PhD or MS with extensive experience in GMP-regulated biologics environments.
• Experience leading scientists or laboratory teams.
• Strong knowledge of GMP requirements and data integrity.

Responsibilities

• Lead and develop a growing team of scientists and leaders for GMP analytical testing.
• Oversee batch-release and stability testing to ensure timely, compliant results.
• Build organizational structure and leadership capacity to support significant growth.
• Guide analytical method validation and transition from development to GMP.
• Ensure readiness for new manufacturing capabilities and facilities.

Skills

Leadership

GMP analytics

Biologics testing

Method validation

Education

Ph.D. in analytical chemistry/biochemistry/biotechnology/pharmaceutical sciences

MS with 10+ years

BS with 14+ years

Job description

Merck in Rahway, NJ seeks a Director to lead a growing GMP analytical team supporting biologics manufacturing. The role encompasses reliable analytical delivery, people development, and maintaining a rigorous quality culture during expansion into ADC, sterile filling, and monoclonal antibody production.

The candidate will lead batch-release and stability testing, oversee investigations, and partner with cross-functional teams to align testing priorities and risk management.