GMP Analytics Lead: Associate Principal Scientist (2nd Shift)

Merck & Co.; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co. in Rahway, NJ seeks an Associate Principal Scientist to supervise a team of specialists and scientists across GMP analytical activities for drug substance and product.

The role emphasizes second-shift operations, method validation, cleaning verification, and in-process testing to support the non-sterile clinical portfolio. You will ensure timely, compliant analytical testing, oversee lab investigations and deviations, and drive process improvements while collaborating with Global

Qualifications

• Excellent scientific communication skills.
• Demonstrated creativity.
• Effective interpersonal and collaborative skills.
• Demonstrated ability to lead teams to deliver high-quality results against firm deadlines.
• Ability to partner in a team environment with cross-functional interactions to drive results.

Responsibilities

• Supervise a team of specialists and scientists supporting cleaning verification, solvent release, and in-process testing during 2nd shift.
• Support GMP analytical activities including cleaning verification, method validation and in-process testing.
• Document execution, procedures, results and conclusions following ALCOA+ principles.
• Ensure on-time, right-first-time analytical testing for clinical manufacture.
• Provide technical and compliance oversight for lab investigations and deviations.
• Review and approve GMP data, analytical reports, and SOPs.
• Drive operational excellence and process improvements.
• Collaborate with Global Development Quality and Pharmaceutical Operations.
• Support internal and external compliance audit activities.

Skills

Excellent scientific communication

Creative thinking

Interpersonal & collaborative skills

Lead teams to high-quality results

Cross-functional partnership

Education

BS/MS in chemistry or related science

PhD in chemistry or related science

Job description

Merck & Co. in Rahway, NJ seeks an Associate Principal Scientist to supervise a team of specialists and scientists across GMP analytical activities for drug substance and product.

The role emphasizes second-shift operations, method validation, cleaning verification, and in-process testing to support the non-sterile clinical portfolio. You will ensure timely, compliant analytical testing, oversee lab investigations and deviations, and drive process improvements while collaborating with Global