Senior Biochemist

Smart Media; Chantilly (VA); On-site; USD 70,000 - 100,000; Full time

Job summary

Granules Pharmaceuticals Inc. (GPI) operates in Chantilly and Manassas, VA, with a focus on analytical testing of raw materials and finished products.

The role requires a Master’s degree and hands-on experience with HPLC/UPLC, UV-Vis, GC, and dissolution methods to support stability and bioequivalence studies. The candidate will develop and validate analytical methods, perform dissolution testing, and interpret data to ensure FDA-compliant release and quality control decisions at our Chantilly

Qualifications

• Master's degree in biochemistry, chemistry, or biotechnology required.
• Working knowledge in HPLC/UPLC, UV-Vis, GC, OOS/OOT, Root Cause Analysis, and dissolution.

Responsibilities

• Conduct analytical/microbiological testing of materials and finished products for stability.
• Analyze product bioequivalence using UV-Vis, GC, FTIR and TLC.
• Identify and develop analytical methods to compare dissolution profiles and in-vivo studies using cGMP/cGLP, Empower, pH meter, dissolution and Malvern Mastersizer 2000.
• Perform solubility studies of drug substances per BCS and FDA regulations.
• Coordinate and execute microbiological testing per USP/USP-NF using OOS/OOT and Root Cause Analysis.
• Compile and analyze laboratory test data using API and dosage forms with wet chemistry, HPLC/GC/IC, DSC/TGA/EM, particle size analyzers, UV-Vis/FT-IR.
• Interpret results and ensure data meet specifications and control limits for release.

Skills

HPLC/UPLC

UV-Vis

GC

OOS/OOT

Root Cause Analysis

Dissolution

Education

Master's degree in Biochemistry, Chemistry, or Biotechnology

Tools

Empower

Malvern Mastersizer 2000

DSC/TGA

Job 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.