Bioanalytical Chemist — Pharma QC & Bioequivalence Expert

Granules Pharmaceuticals, Inc.; Chantilly (VA); On-site; USD 69,564 - 73,000; Full time

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

Skills

HPLC

UV-Vis

FTIR

OOS/OOT

Dissolution

Titration

cGMP

LIMS

Education

Bachelor's in Biochemistry/Chemistry/Biotechnology

Tools

Empower

Job description

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