Scientist II, Inhalation Research and Development-NC

Division Overview Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992. Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. Aurobindo markets over 80% of the top 100 most prescribed products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We are#27 in 2010) Job Overview Capable of performing characterization studies for inhalation products, particularly for metered dose inhalers (MDIs). Experienced in developing, validating, and executing test methods for the characterization of MDIs. Should be able to write SOPs, test methods, method validation protocols and reports as per FDA and ICH guidelines and should follow cGMP. Excellent oral and written communication skills and able to thrive in a team environment. Responsibilities Will perform inhalation testing for inhalation products, particularly MDIs. Will be proficient in MDI characterization methods including total can assay, aerodynamic particle size by cascade impaction, delivered dose through container life, Karl Fischer, spray pattern& plume geometry, foreign particulate matter, and microscopic evaluation. Will work with analytical scientists to support their development of assay and impurities methods and for routine testing. Capable of troubleshooting methods. Prepares SOPs, protocols, and reports. Meets timelines. Performs studies according to the stage-appropriate quality system. Qualifications - Skills & Requirements Proficient in developing, validating, and executing MDI characterization methods Must be able to perform laboratories duties that require standing for up to 90% of the work day, lifting containers containing 4+L of liquids and fine motor skills for conducting laboratory experiments (including weighing and pipetting). Education & Experience BS in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific field with 6+ years' experience or MS with 4+ years' experience. At least one year of experience in MDI product development PREFERRED cGMP pharmaceutical experience Compensation Min USD $70,000.00/Yr. Max USD $80,000.00/Yr. Physical Requirements LAB TECHNICIANS - Must be able to bend at the waist and knees as well as twist at the trunk. Must practice good personal hygiene Must be able to lift up to 25 lbs. Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Position requires working in the laboratory as well as sitting Additional Physical Requirements Sitting 1-4 HoursStanding 1-4 HoursWalking 1-4 Hours Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.