GMP Analytical Scientist: API Testing & Validation

Merck; Rahway (NJ); On-site; USD 85,000 - 110,000; Full time

Job summary

Merck & Co. in Rahway, NJ, is seeking an analytical chemist to contribute to GMP method validation and analytical development for APIs and formulations. The role emphasizes collaboration with R&D and tight data integrity in a fast-paced pharmaceutical setting.

You will work with chromatography, dissolution, and physical chemistry techniques, ultimately supporting high-priority drug candidates while maintaining rigorous SOPs and documentation.

Qualifications

• Minimum 1 year of pharmaceutical experience.
• Strong technical skills and proficiency in analytical laboratory techniques.
• GMP experience and understanding of GMP processes and SOP governance.
• Ability to work under the direction of a laboratory supervisor.

Responsibilities

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

Skills

Analytical Chemistry

Chromatography

HPLC

GC

Dissolution

Karl Fischer

Particle size analysis

Viscometry

Laboratory Techniques

GMP

Education

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

Tools

SDLC

Job description

Merck & Co. in Rahway, NJ, is seeking an analytical chemist to contribute to GMP method validation and analytical development for APIs and formulations. The role emphasizes collaboration with R&D and tight data integrity in a fast-paced pharmaceutical setting.

You will work with chromatography, dissolution, and physical chemistry techniques, ultimately supporting high-priority drug candidates while maintaining rigorous SOPs and documentation.