Director, Biologics Analytics & GMP Operations

Merck; New Jersey; On-site; USD 220,000 - 320,000; Full time

Job summary

Merck in Rahway, NJ seeks a Director to lead a growing GMP analytical team supporting biologics manufacturing. The role drives analytical delivery, people development, and capability expansion across ADCs and mAb production in Next Gen Bio.

Strong quality, safety and data integrity are essential as the portfolio scales. The position requires senior leadership experience in GMP analytics, method validation, and cross-functional collaboration to ensure reliable, timely analytical results for

Qualifications

• PhD or MS with extensive pharmaceutical experience and leadership required.
• Strong GMP operations and inspection readiness capabilities.
• Experience leading analytical testing for biologics and ADCs.

Responsibilities

• Lead and develop a growing GMP analytical team across biologics operations.
• Build organizational structure, workforce plan and leadership capacity.
• Maintain culture of quality, data integrity and accountability.
• Provide leadership for batch-release and stability testing.
• Coordinate with Manufacturing, Quality, regulatory and analytical development teams.

Education

PhD in analytical chemistry/biochemistry/biotechnology/pharmaceutical sciences

MS in related field

BS in related field

Job description

Merck in Rahway, NJ seeks a Director to lead a growing GMP analytical team supporting biologics manufacturing. The role drives analytical delivery, people development, and capability expansion across ADCs and mAb production in Next Gen Bio.

Strong quality, safety and data integrity are essential as the portfolio scales. The position requires senior leadership experience in GMP analytics, method validation, and cross-functional collaboration to ensure reliable, timely analytical results for