Senior Biochemist

Granules Pharmaceuticals, Inc.; Chantilly (VA); On-site; USD 86,000 - 89,000; Full time

Job summary

Granules Pharmaceuticals Inc. (GPI) in Chantilly, VA, is seeking an analytical chemist to conduct stability testing of raw materials and finished products.

You will analyze bioequivalence using UV-Vis, GC, FTIR, and TLC, and develop methods for dissolution profiling to support regulatory submissions. The role requires a Master’s degree in Biochemistry, Chemistry, or Biotechnology and hands-on experience with HPLC/UPLC, UV-Vis, GC, and dissolution testing in a cGMP environment.

Qualifications

• Master's degree in Biochemistry, Chemistry, or Biotechnology.
• Strong knowledge of HPLC/UPLC, UV-Vis, and GC.
• Experience with OOS/OOT, Root Cause Analysis, and dissolution testing.

Responsibilities

• Conduct analytical/microbiological testing for stability of materials and products.
• Analyze bioequivalence using UV-Vis, GC, FTIR, TLC.
• Develop analytical methods for dissolution profile comparisons.
• Coordinate testing per USP/USP-NF and manage OOS/OOT investigations.
• Compile data from HPLC/GC/UV-Vis and other instruments and interpret results.
• Ensure data meet release specifications.

Skills

Root Cause Analysis

Dissolution

OOS/OOT

Education

Master's degree in Biochemistry, Chemistry, or Biotechnology

Tools

HPLC/UPLC

UV-Vis

GC

pH meter

Empower

Job description

Job Type

Full-time

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.

Salary Description

$86.3k - $89k/yr