Biochemist

Granules Pharmaceuticals, Inc.; Chantilly (VA); On-site; USD 69,564 - 73,000; Full time

Job summary

Granules Pharmaceuticals, Inc. is seeking a QC Analyst to assess bio-availability and bioequivalence of pharmaceutical products.

Responsibilities include routine release testing of materials and finished products, as well as in-vivo dissolution studies aligned with cGMP/cGLP, Empower, and analytical methods such as HPLC and UV-Vis. The ideal candidate will hold a Bachelor's degree in Biochemistry, Chemistry, or Biotechnology and have at least two years in Quality Control within pharma

Qualifications

• Bachelor's degree in Biochemistry, Chemistry, or Biotechnology + 2 years experience in Quality Control within a Pharmaceutical Manufacturing company.
• Working knowledge in HPLC, UV-Vis, FTIR, OOS/OOT, Dissolution, Titration, cGMP, LIMS

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

HPLC

UV-Vis

FTIR

OOS/OOT

Dissolution

Titration

cGMP

LIMS

Education

Bachelor's in Biochemistry/Chemistry/Biotechnology

Tools

Empower

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.

Job Type

Full-time

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

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

Salary Description

$69,564~$73,000/year