Biochemist, QC

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 commercialisation of generic drugs to give customers reliable and affordable options.

Responsibilities:

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

Submit rsum referencing job code ASY001 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151

Educational Requirements:

Must have a Bachelor’s degree in Biochemistry, Chemistry, or Biotechnology plus 2 years experience in Quality Control within a Pharmaceutical Manufacturing company.

Skills Requirements:

Skills and knowledge in HPLC, UV-Vis, FTIR, OOS/OOT, Dissolution, Titration, cGMP, LIMS

We believe in fair and transparent pay practices. Actual compensation is determined based on relevant experience, qualifications, skills, and internal equity.