GMP Analytical Scientist - Drug Development & Validation

MSD Malaysia; Rahway, Northern (NJ, KY); Hybrid; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical insurance

401(k) retirement benefits

Paid holidays

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a GMP Analytical Scientist to validate methods for APIs, excipients, and drug products. You will support a pilot plant, work with R&D leads on project needs, and ensure compliant documentation and data integrity.

The role emphasizes analytical chemistry, chromatography (HPLC/GC), dissolution, and physico-chemical characterization, with collaboration across a GMP environment. Strong communication skills are essential.

Qualifications

• Bachelor's degree or higher in Chemistry, Pharmacy, or a related scientific discipline.
• Minimum 1 year of pharmaceutical experience and GMP exposure.
• Strong technical skills with analytical laboratory techniques and data integrity.

Responsibilities

• Execute GMP method validation for APIs, excipients, and formulated drug products (e.g., tablets, topicals, solutions, implants).
• Support pilot manufacturing plant testing of APIs, excipients, packaging materials, and cleaning samples.
• Collaborate with R&D leads to assess project needs, timelines, and prioritization.
• Maintain high-quality documentation and data integrity; prepare technical reports.
• Support analytical development of high-priority drug candidates.

Skills

Analytical techniques

HPLC

GC

Dissolution

Karl Fischer

Particle size

Viscometry

Texture Analysis

Auto titration

Data analysis

GMP environment

Laboratory documentation

Education

Bachelor's degree in Chemistry, Pharmacy, or other scientific discipline

Tools

Software validation (SDLC)

Job description

Merck & Co., Inc. in Rahway, NJ is seeking a GMP Analytical Scientist to validate methods for APIs, excipients, and drug products. You will support a pilot plant, work with R&D leads on project needs, and ensure compliant documentation and data integrity.

The role emphasizes analytical chemistry, chromatography (HPLC/GC), dissolution, and physico-chemical characterization, with collaboration across a GMP environment. Strong communication skills are essential.