Senior Biochemist

About the role

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.

Responsibilities

• 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 establish specifications and control limits to ensure appropriateness of data for release

Requirements

• Master degree in Biochemistry, Chemistry, or Biotechnology
• Skills and working knowledge in HPLC/UPLC, UV-Vis, GC, OOS/OOT, Root Cause Analysis, Dissolution