Biochemist
About the Company
Granules Pharmaceuticals Inc. (GPI) is a subsidiary of Granules India LTD. With over 34 years in the industry, GPI is the 10th fastest-growing generic pharma company in the US. Our facilities in Chantilly and Manassas, Virginia, encompass 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 committed to excellence in manufacturing, quality, and commercialization of generic drugs, providing reliable and affordable options for customers.
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 the 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.
Submit résumé referencing job code ASY001 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151.