Senior Chemist

MSN Pharmaceuticals Inc.; New Jersey; On-site; USD 90,000 - 120,000; Full time

Job summary

MSN Pharmaceuticals Inc. in New Jersey is seeking a QC Senior Chemist to oversee quality control operations in an FDA-regulated cGMP environment, testing raw materials, in-process blends, and finished drug products.

You will perform analytical testing using HPLC, GC, UV-Vis, Karl Fischer, IR, and dissolution instruments; ensure data integrity and support method validation, transfer, and audits. 5–10 years of experience required.

Qualifications

• 5–10 years pharmaceutical QC experience.
• Experience with HPLC/GC/UV-Vis and dissolution techniques.
• Familiarity with FDA, cGMP, GLP, GDP, USP/NF and data integrity.

Responsibilities

• Oversee QC operations and test raw materials, in-process blends, and finished products.
• Perform and review analytical testing using listed instruments.
• Calibrate instruments, perform system suitability checks, troubleshoot, and maintain equipment.
• Review CoAs and laboratory records for accuracy and compliance.
• Investigate OOS/OOT results, deviations, and CAPA delivery.
• Ensure compliance with FDA, cGMP, GLP, GDP, USP/NF, and data integrity standards.
• Support method validation, verification, transfer, and stability studies.
• Provide guidance and training to QC staff and junior personnel.
• Coordinate with QA and Production to resolve quality issues; support audits and inspections.

Skills

Analytical testing

Quality control

Regulatory compliance

Tools

HPLC

GC

UV-Vis

Karl Fischer

IR

Dissolution testing

Job description

Job Title: QC Senior Chemist (Full Time)

Job Summary:

Oversee pharmaceutical quality control operations by testing raw materials, in-process blends, and finished drug products in an FDA-regulated cGMP environment.

Core Responsibilities:

• Perform and review analytical testing using HPLC, GC, UV-Vis, Karl Fischer,IR,SOR,DT and dissolution instruments.
• Conduct instrument calibration, system suitability checks, troubleshooting, and routine maintenance.
• Review analytical data, laboratory records, and Certificates of Analysis (CoAs) for accuracy and compliance.
• Investigate OOS/OOT results, deviations, and laboratory discrepancies; support root cause analysis and CAPA.
• Ensure compliance with FDA, cGMP, GLP, GDP, USP/NF, and data integrity requirements.
• Support analytical method validation, verification, transfer, and stability studies.
• Provide technical guidance and training to QC Chemists and junior laboratory personnel.
• Coordinate with QA and Production teams to resolve quality-related issues.
• Support internal audits, regulatory inspections, and continuous improvement initiatives.

Requirements:

5–10 years pharmaceutical Quality Control experience in pharmaceutical