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Scientist - Pharmaceutical Formulation Development

2 months ago

Durham North Carolina, United States Aurobindo Pharma USA, Inc. Full time
Job Overview

Aurobindo Pharma USA, Inc. is a leading generic pharmaceutical company seeking a highly skilled Scientist to join our team in the development of complex formulations, particularly inhalation products. The ideal candidate will have a strong background in HPLC and GC, with experience in method validation and development.

Responsibilities
  • Develop and validate analytical test methods for complex formulations, with a focus on GC methods.
  • Perform hands-on lab work and coordinate with junior level analytical staff.
  • Provide routine characterization of R&D formulations and analytical support for studies necessary for chemistry and manufacturing controls.
  • Troubleshoot methods and work with formulation scientists in developing assay methods, fast LC methods, and transferring methods to the quality control laboratory.
  • Draft test methods, method validation protocols, and reports as per FDA and ICH guidelines.
Qualifications
  • BS with 5+ years of experience in pharmaceuticals or related field, or MS in Science with 3+ years of experience.
  • Experience in test method validation, HPLC, and GC, including strong GC MD skills.
  • Ability to perform laboratory duties that require standing for up to 90% of the work day, lifting containers containing up to 4+L of liquids, and fine motor skills for conducting laboratory experiments.
  • Experience with test method development, MDI product testing, and developing generic products, including inhalation products.
  • Familiarity with cGMP regulations, FDA guidance documents, and QbD.
Physical Requirements
  • Ability to bend at the waist and knees, twist at the trunk, and lift up to 25 lbs.
  • Ability to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.