Biochemist: Bioanalysis & QC for Pharma

Granules Pharmaceuticals Inc.; Chantilly, Northern (VA, KY); Hybrid; USD 80,000 - 105,000; Full time

Job summary

Granules Pharmaceuticals Inc. in Chantilly, VA seeks a Quality Control specialist to support bio-analytical testing, release, and impurity studies for generic products. The role emphasizes adherence to cGMP, regulatory guidelines, and data integrity within a manufacturing setting.

You will perform HPLC/UV-Vis/FTIR analyses, OOS/OOT investigations, and dissolution studies while coordinating impurity assessments and data interpretation to ensure product quality and compliance.

Qualifications

• Bachelor’s degree in Biochemistry, Chemistry, or Biotechnology and 2 years experience in Quality Control within a Pharmaceutical Manufacturing company.
• Experience in pharmaceutical quality control operations.

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

Bio-analytical testing

Regulatory compliance

Data interpretation

Education

Bachelor's degree in Biochemistry/Chemistry/Biotechnology

Tools

HPLC

UV-Vis

FTIR

OOS/OOT

Dissolution

Titration

cGMP

LIMS

Job description

Granules Pharmaceuticals Inc. in Chantilly, VA seeks a Quality Control specialist to support bio-analytical testing, release, and impurity studies for generic products. The role emphasizes adherence to cGMP, regulatory guidelines, and data integrity within a manufacturing setting.

You will perform HPLC/UV-Vis/FTIR analyses, OOS/OOT investigations, and dissolution studies while coordinating impurity assessments and data interpretation to ensure product quality and compliance.