Posted on OINDPnews on June 29, 2018.
Company: Aurobindo Pharma USA, Inc.
Status: Full time
Location: 2929 Weck Drive, Durham, NC 27703
Description
In this role, you will be designing and independently conducting studies in support of metered dose inhaler (MDI) product development, with focus on formulation and process development. You will be routinely working with manufacturing equipment and testing apparatus / instruments.
The candidate should have strong understandings of MDI formulation, components, and performance testing, with good knowledge of cGMP guidelines, FDA / ICH / USP guidances / monographs. Candidate also needs to have excellent problem solving and communication skills. Able to thrive in a team environment.
Core Duties and Essential Job Functions
o Perform device and formulation reverse engineering studies.
o Formulate and fill solution and suspension MDIs.
o Conduct characterization studies using methods including aerodynamic particle size by cascade impaction, delivered dose through container life, particle size by laser diffraction, spray pattern & plume geometry.
o Perform API solid state characterization studies.
o Troubleshoot equipment and methods.
o Prepare SOPs, protocols, and reports. Meet timelines and perform work according to the stage-appropriate quality system.
Requirements
• PhD (preferred), MS, or BS in Chemistry, Pharmaceutical Sciences, or related field with experience in MDI product development
• Strong understanding of MDI formulation and testing.
• Able to wear a respirator.
• Experience with statistical design of experiments (DoE) and Quality by Design (QbD) is a plus.
Please send resumes to: HRNC@aurobindousa.com
