GMP Analytical Scientist Lead (2nd Shift)

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

Job summary

Merck Rahway, NJ seeks an Associate Principal Scientist to lead a GMP analytical lab on the 2nd shift, supporting cleaning verification, solvent release and in-process testing for drug substance and product. You will supervise a team of scientists, ensure ALCOA+-compliant documentation and enable clinical manufacturing through timely testing.

The role requires strong scientific communication, leadership, and collaboration across QA, Global Development Quality, and Pharmaceutical Operations, with

Qualifications

• BS or MS in chemistry with 7+ years of pharma drug substance/product development experience.
• Ph.D. in chemistry with 3+ years of pharma drug substance/product development experience.

Responsibilities

• Supervise a team of scientists performing GMP analytical activities (cleaning verification, solvent release, in-process testing) during 2nd shift.
• Ensure GMP data, reports, and SOPs are documented and compliant (ALCOA+).
• Oversee lab investigations/deviations and provide technical/compliance support.
• Review and approve analytical data and SOPs; drive process improvements.
• Collaborate with Global Development Quality and Pharmaceutical Operations; support audits.

Skills

Scientific communication

Creativity

Interpersonal skills

Team leadership

Cross-functional collaboration

Education

BS/MS in Chemistry

PhD in Chemistry

Tools

HRMS

LC-MS

Analytical Method Development

Process Development

GMP Compliance

Regulatory Audits

PAT

Protein Analysis

Job description

Merck Rahway, NJ seeks an Associate Principal Scientist to lead a GMP analytical lab on the 2nd shift, supporting cleaning verification, solvent release and in-process testing for drug substance and product. You will supervise a team of scientists, ensure ALCOA+-compliant documentation and enable clinical manufacturing through timely testing.

The role requires strong scientific communication, leadership, and collaboration across QA, Global Development Quality, and Pharmaceutical Operations, with