Senior GMP Analytics Lead – 2nd Shift

Merck; New Jersey; On-site; USD 150,000 - 190,000; Full time

Job summary

Merck in Rahway, NJ, seeks an Associate Principal Scientist to lead a GMP analytical team on 2nd shift, supporting cleaning verification, method validation, solvent release, and in-process testing for drug substance and drug product.

You will mentor scientists, ensure ALCOA+ compliant data handling, and drive process improvements while collaborating with Global Development Quality and Pharmaceutical Operations. PhD or MS with relevant experience is required.

Qualifications

• BS or MS in chemistry or related science with 7+ years pharma industry experience.
• Ph.D. in chemistry or related science with 3+ years pharma industry experience.
• Excellent scientific communication skills.
• Demonstrated creativity and leadership in GMP analytics.

Responsibilities

• Supervise a team of specialists and scientists on GMP analytical activities (cleaning verification, method validation, solvent release, in-process testing).
• Oversee documentation of experiments, results, and conclusions per ALCOA+ principles.
• Ensure on-time, right-first-time analytical testing to enable clinical manufacture.
• Provide technical/compliance oversight for lab investigations and deviations and troubleshoot as needed.

Skills

Analytical Method Dev

Analytical Testing

Assay Development

Biological Assay Dev

Cell-Based Assays

Chromatography

Cleaning Validations

Drug Development

HRMS

LC-MS

Process Development

PAT

Protein Analysis

Regulatory Audits

Education

BS or MS in chemistry or related science

Ph.D. in chemistry or related science

Job description

Merck in Rahway, NJ, seeks an Associate Principal Scientist to lead a GMP analytical team on 2nd shift, supporting cleaning verification, method validation, solvent release, and in-process testing for drug substance and drug product.

You will mentor scientists, ensure ALCOA+ compliant data handling, and drive process improvements while collaborating with Global Development Quality and Pharmaceutical Operations. PhD or MS with relevant experience is required.