Bioequivalence & QC Scientist

Granules Pharmaceuticals; Chantilly (VA); On-site; USD 60,000 - 85,000; Full time

Job summary

Granules Pharmaceuticals Inc. (GPI) seeks a quality control specialist in Chantilly, Virginia, to analyze bio-availability and bioequivalence tests and perform routine release testing of raw materials and finished products using HPLC, UV-Vis, and other techniques.

The role requires a Bachelor’s degree in Biochemistry, Chemistry, or Biotechnology and at least two years of QA/QC experience in a pharmaceutical manufacturing environment.

Qualifications

• Must have a Bachelor’s degree in Biochemistry, Chemistry, or Biotechnology plus 2 years experience in Quality Control within a Pharmaceutical Manufacturing company.
• Working knowledge in HPLC, UV-Vis, FTIR, OOS/OOT, Dissolution, Titration, cGMP, LIMS.

Responsibilities

• Analyze bio-availability and bioequivalency 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

Education

Bachelor’s degree in Biochemistry, Chemistry, or Biotechnology

Tools

HPLC

UV-Vis

FTIR

OOS/OOT

Dissolution

Titration

cGMP

LIMS

Job description

Granules Pharmaceuticals Inc. (GPI) seeks a quality control specialist in Chantilly, Virginia, to analyze bio-availability and bioequivalence tests and perform routine release testing of raw materials and finished products using HPLC, UV-Vis, and other techniques.

The role requires a Bachelor’s degree in Biochemistry, Chemistry, or Biotechnology and at least two years of QA/QC experience in a pharmaceutical manufacturing environment.