Bioanalytical Chemist — Pharma QC & Bioequivalence Expert

Granules Pharmaceuticals, Inc.

Chantilly (VA)

On-site

USD 69,564 - 73,000

Full time

14 days+

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Job summary

Granules Pharmaceuticals, Inc. is seeking a QC Analyst to assess bio-availability and bioequivalence of pharmaceutical products.

Responsibilities include routine release testing of materials and finished products, as well as in-vivo dissolution studies aligned with cGMP/cGLP, Empower, and analytical methods such as HPLC and UV-Vis. The ideal candidate will hold a Bachelor's degree in Biochemistry, Chemistry, or Biotechnology and have at least two years in Quality Control within pharma

Qualifications

Bachelor's degree in Biochemistry, Chemistry, or Biotechnology + 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