Granules

Vertically integrated API and dosage manufacturer

Senior Biochemist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeChantilly, VA, USANo salary listedIn-person

About the Job

Requirements

A Master's degree in Biochemistry, Chemistry, or Biotechnology is required.
Skills and working knowledge in high-performance liquid chromatography and ultra-performance liquid chromatography, ultraviolet-visible spectroscopy, gas chromatography, out-of-specification and out-of-trend handling, root cause analysis, and dissolution are required.

Responsibilities

Conduct analytical and microbiological testing of raw materials and finished pharmaceutical products for stability using high-performance liquid chromatography, ultra-performance liquid chromatography, and potentiometry.
Analyze product bioequivalence using next-generation sequencing, ultraviolet-visible spectroscopy, gas chromatography, Fourier-transform infrared spectroscopy, and thin-layer chromatography.
Identify and develop analytical methods to compare dissolution profiles and processes for in-vivo bioequivalence studies using current good manufacturing practices, current good laboratory practices, Empower, a pH meter, dissolution equipment, and a Malvern Mastersizer 2000.
Perform solubility studies of drug substances according to the Biopharmaceutics Classification System and Food and Drug Administration regulations.
Coordinate and execute microbiological testing according to United States Pharmacopeia and USP-NF using out-of-specification and out-of-trend handling and root cause analysis.
Compile and analyze laboratory test data for physical, biochemical, chemical, and analytical testing of active pharmaceutical ingredients and pharmaceutical dosage forms using wet chemistry, high-performance liquid chromatography, gas chromatography, ion chromatography, differential scanning calorimetry, thermogravimetric analysis, an electron microscope, X-ray diffraction, particle size analyzers, ultraviolet-visible spectroscopy, and Fourier-transform infrared spectroscopy.
Interpret test results and established specifications and control limits to ensure data are appropriate for release.

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.

Submit résumé referencing job code SWT002 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151.

About the Company

Granules

Vertically integrated API and dosage manufacturer

Granules India manufactures Active Pharmaceutical Ingredients, Pharmaceutical Formulation Intermediates, and Finished Dosages for customers in more than 80 countries, leveraging large-scale, cost-efficient production. Its vertical integration means it controls the production chain from base chemicals to final packaged medicines, while also marketing its own label products in the US via Granules Pharmaceuticals Inc. The company differentiates itself through a global manufacturing footprint, scale, and an integrated supply chain that supports both contract manufacturing and branded products, including advanced areas like MUPS, oncology, and peptide therapeutics. Its goal is to provide globally accessible, affordable medicines by maintaining secure supply and expanding capabilities in complex therapies, while pursuing sustainability through green chemistry and net-zero emissions.

Company size: 501-1,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Not listed
Founded: 2014

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