Senior Biochemist

Granules Pharmaceuticals; Chantilly (VA); On-site; USD 70,000 - 110,000; Full time

Job summary

Granules Pharmaceuticals Inc. is seeking a qualified analyst to conduct analytical and microbiological testing across raw materials and finished products for stability using HPLC/UPLC, UV-Vis, GC, and related techniques.

The role requires a Master’s degree in Biochemistry, Chemistry, or Biotechnology and hands-on experience with OOS/OOT investigations, dissolution profiling, and data interpretation per cGMP standards.

Qualifications

• Master degree in Biochemistry, Chemistry, or Biotechnology.
• Experience with HPLC/UPLC, UV-Vis, GC.
• Knowledge of OOS/OOT and Root Cause Analysis.
• Familiarity with dissolution testing.

Responsibilities

• Conduct analytical/microbiological testing of raw materials and finished products for stability using HPLC/UPLC, Potentiometry.
• Analyze product bioequivalence using UV-Vis, GC, FTIR and TLC.
• Coordinate and execute microbiological testing per USP/USP-NF with OOS/OOT and Root Cause Analysis.
• Compile and analyze lab data for APIs and dosage forms using wet chemistry, HPLC/GC/IC, DSC/TGA and UV-Vis/FT-IR.
• Interpret test results and ensure data meet specifications 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

pH meter

Malvern Mastersizer 2000

UV-Vis spectroscopy

GC

DSC/TGA

XRD

Job description

Description

Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, we have worked towards strengthening our core and we are currently the 10th fastest growing generic pharma company in the US!

With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.

We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.

Primary Accountabilities

• Conduct analytical/microbiological testing of raw materials and finished pharmaceutical products for stability using HPLC/UPLC, Potentiometry
• Analyze product bio equivalency using next generation sequencing, UV-Vis, GC, FTIR and TLC
• Identify and develop analytical Methods to compare dissolution profiles and process for in-vivo bioequivalence studies using cGMP/cGLP, Empower, pH meter, dissolution and Malvern Mastersizer 2000
• Perform solubility studies of drug substances as per Bio-Pharmaceutics classification system (BCS) in accordance with FDA regulations
• Coordinate and execute microbiological testing as per USP/USP-NF using OOS/OOT, Root Cause Analysis
• Compile and analyze laboratory test data for physical, biochemical, chemical, and analytical testing using Active Pharmaceutical Ingredients (API) and pharmaceutical dosage forms using wet chemistry, HPLC/GC/IC, DSC/TGA/electron microscope/XRD, particle size analyzers, and UV-Vis/FT-IR
• Interpret test results and established specifications and control limits to ensure appropriateness of data for release.

Requirements

Must have a Master degree in Biochemistry, Chemistry, or Biotechnology plus skills and working knowledge in HPLC/UPLC, UV-Vis, GC, OOS/OOT, Root Cause Analysis, Dissolution.