Senior Biochemist

Granules Pharmaceuticals Inc.; Chantilly, Northern (VA, KY); Hybrid; USD 70,000 - 110,000; Full time

Job summary

Granules Pharmaceuticals Inc. in Chantilly, Virginia is seeking an Analytical Scientist to support analytical testing, dissolution studies, and BE activities in a GMP environment.

The role involves stability testing, method development, and data interpretation to ensure compliant release of generic medicines. Candidates should hold a Master’s degree in Biochemistry, Chemistry, or Biotechnology and have hands-on experience with HPLC/UPLC, UV-Vis, GC, andFDA-regulated workflows in a fast-paced

Qualifications

• Master's degree in Biochemistry, Chemistry, or Biotechnology.
• Experience with HPLC/UPLC, UV-Vis, GC.
• Knowledge of OOS/OOT and root cause analysis.
• Experience with dissolution testing per FDA regulations.
• Ability to analyze data and interpret results for release.

Responsibilities

• Conduct analytical/microbiological testing for stability using HPLC/UPLC.
• Analyze product bioequivalence using UV-Vis, GC, FTIR, TLC.
• Develop methods to compare dissolution profiles for in-vivo BE studies.
• Perform solubility studies per BCS and FDA regulations.
• Coordinate and execute microbiological testing per USP standards.
• Compile and analyze lab data using API and dosage forms.
• Interpret results against specifications to ensure release.

Skills

Analytical testing

Bioanalytical skills

Root Cause Analysis

Dissolution testing

Education

Master's degree in Biochemistry, Chemistry, or Biotechnology

Tools

HPLC/UPLC

UV-Vis

GC

Dissolution

OOS/OOT

DSC/TGA

XRD

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.

Primary Accountabilities

• Conduct analytical/microbiological testing of raw materials and finished pharmaceutical products for stability using HPLC/UPLC, Potentiometry
• Analyze product bio equivalency using next generation sequencing, UV-Vis, GC, FTIR and TLC
• Identify and develop analytical Methods to compare dissolution profiles and process for in-vivo bioequivalence studies using cGMP/cGLP, Empower, pH meter, dissolution and Malvern Mastersizer 2000
• Perform solubility studies of drug substances as per Bio-Pharmaceutics classification system (BCS) in accordance with FDA regulations
• Coordinate and execute microbiological testing as per USP/USP-NF using OOS/OOT, Root Cause Analysis
• Compile and analyze laboratory test data for physical, biochemical, chemical, and analytical testing using Active Pharmaceutical Ingredients (API) and pharmaceutical dosage forms using wet chemistry, HPLC/GC/IC, DSC/TGA/electron microscope/XRD, particle size analyzers, and UV-Vis/FT-IR
• Interpret test results and established specifications and control limits to ensure appropriateness of data for release.

Requirements

Must have a Master degree in Biochemistry, Chemistry, or Biotechnology plus skills and working knowledge in HPLC/UPLC, UV-Vis, GC, OOS/OOT, Root Cause Analysis, Dissolution.