Senior Biochemist: Bioanalysis & BE Specialist

Smart Media; Chantilly (VA); On-site; USD 70,000 - 100,000; Full time

Job summary

Granules Pharmaceuticals Inc. (GPI) operates in Chantilly and Manassas, VA, with a focus on analytical testing of raw materials and finished products.

The role requires a Master’s degree and hands-on experience with HPLC/UPLC, UV-Vis, GC, and dissolution methods to support stability and bioequivalence studies. The candidate will develop and validate analytical methods, perform dissolution testing, and interpret data to ensure FDA-compliant release and quality control decisions at our Chantilly

Qualifications

• Master's degree in biochemistry, chemistry, or biotechnology required.
• Working knowledge in HPLC/UPLC, UV-Vis, GC, OOS/OOT, Root Cause Analysis, and dissolution.

Responsibilities

• Conduct analytical/microbiological testing of materials and finished products for stability.
• Analyze product bioequivalence using UV-Vis, GC, FTIR and TLC.
• Identify and develop analytical methods to compare dissolution profiles and in-vivo studies using cGMP/cGLP, Empower, pH meter, dissolution and Malvern Mastersizer 2000.
• Perform solubility studies of drug substances per BCS and FDA regulations.
• Coordinate and execute microbiological testing per USP/USP-NF using OOS/OOT and Root Cause Analysis.
• Compile and analyze laboratory test data using API and dosage forms with wet chemistry, HPLC/GC/IC, DSC/TGA/EM, particle size analyzers, UV-Vis/FT-IR.
• Interpret results and ensure data meet specifications and control limits for release.

Skills

HPLC/UPLC

UV-Vis

GC

OOS/OOT

Root Cause Analysis

Dissolution

Education

Master's degree in Biochemistry, Chemistry, or Biotechnology

Tools

Empower

Malvern Mastersizer 2000

DSC/TGA

Job description

Granules Pharmaceuticals Inc. (GPI) operates in Chantilly and Manassas, VA, with a focus on analytical testing of raw materials and finished products.

The role requires a Master’s degree and hands-on experience with HPLC/UPLC, UV-Vis, GC, and dissolution methods to support stability and bioequivalence studies. The candidate will develop and validate analytical methods, perform dissolution testing, and interpret data to ensure FDA-compliant release and quality control decisions at our Chantilly