Biochemist

About the role

Granules Pharmaceuticals Inc. (GPI), a subsidiary of Granules India LTD, is the 10th fastest-growing generic pharma company in the US. With sites in Chantilly and Manassas, Virginia, we specialize in R&D, manufacturing, and packaging of medicines, including pulsatile drug release tablets and capsules, orally disintegrating modified-release tablets (XR, MR, ER), modified-release suspensions, and controlled substances with abuse-deterrent technology. We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to provide reliable and affordable options.

Responsibilities

• Analyze bio-availability and bioequivalency of pharmaceutical products using HPLC, UV-Vis, GC, and FTIR.
• Perform routine release tests of raw materials and finished products using OOS/OOT and LIMS.
• Conduct in-vivo dissolution tests related to the biopharmaceutic characteristics of drug substances and bioequivalence studies using cGMP/cGLP, Empower, Titration, HPLC, and dissolution.
• Perform solubility studies of drug substances as per the Bio-Pharmaceutics Classification System (BCS) in accordance with FDA regulations.
• Conduct and coordinate elemental impurities studies for pharmaceutical products as per ICH guidance.
• Interpret test results and establish specifications and control limits to ensure appropriateness of data for release.
• Analyze biochemical results.

Requirements

• Bachelor’s degree in Biochemistry, Chemistry, or Biotechnology.
• Minimum of 2 years of experience in Quality Control within a Pharmaceutical Manufacturing company.

Skills

• Working knowledge of HPLC, UV-Vis, FTIR, OOS/OOT, Dissolution, Titration, cGMP, and LIMS.

Pay

$69,564–$73,000 per year.