Biochemist

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

Description

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

Responsibilities include but not limited to:

• 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

Requirements

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:

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