Senior Biochemist: Bioanalysis & Bioequivalence Expert

Granules Pharmaceuticals Inc.; Chantilly, Northern (VA, KY); Hybrid; USD 70,000 - 110,000; Full time

Job summary

Granules Pharmaceuticals Inc. in Chantilly, Virginia is seeking an Analytical Scientist to support analytical testing, dissolution studies, and BE activities in a GMP environment.

The role involves stability testing, method development, and data interpretation to ensure compliant release of generic medicines. Candidates should hold a Master’s degree in Biochemistry, Chemistry, or Biotechnology and have hands-on experience with HPLC/UPLC, UV-Vis, GC, andFDA-regulated workflows in a fast-paced

Qualifications

• Master's degree in Biochemistry, Chemistry, or Biotechnology.
• Experience with HPLC/UPLC, UV-Vis, GC.
• Knowledge of OOS/OOT and root cause analysis.
• Experience with dissolution testing per FDA regulations.
• Ability to analyze data and interpret results for release.

Responsibilities

• Conduct analytical/microbiological testing for stability using HPLC/UPLC.
• Analyze product bioequivalence using UV-Vis, GC, FTIR, TLC.
• Develop methods to compare dissolution profiles for in-vivo BE studies.
• Perform solubility studies per BCS and FDA regulations.
• Coordinate and execute microbiological testing per USP standards.
• Compile and analyze lab data using API and dosage forms.
• Interpret results against specifications to ensure release.

Skills

Analytical testing

Bioanalytical skills

Root Cause Analysis

Dissolution testing

Education

Master's degree in Biochemistry, Chemistry, or Biotechnology

Tools

HPLC/UPLC

UV-Vis

GC

Dissolution

OOS/OOT

DSC/TGA

XRD

Job description

Granules Pharmaceuticals Inc. in Chantilly, Virginia is seeking an Analytical Scientist to support analytical testing, dissolution studies, and BE activities in a GMP environment.

The role involves stability testing, method development, and data interpretation to ensure compliant release of generic medicines. Candidates should hold a Master’s degree in Biochemistry, Chemistry, or Biotechnology and have hands-on experience with HPLC/UPLC, UV-Vis, GC, andFDA-regulated workflows in a fast-paced