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 The Scientist I is responsible for the development of metered dose inhaler (MDI) products, including formulation, device, and process development. Capable of performing Product development activities for inhalation products, particularly for metered dose inhalers (MDIs). Experienced in Batch manufacturing, equipment handling, and data evaluation of MDIs. Should be able to write SOPs, development trials, up Protocols, and reports as per FDA and ICH guidelines, and should follow cGMP. Excellent oral and written communication skills, with the ability to thrive in a team environment Responsibilities Generates high quality documents including process documentation, operating instructions, protocols, and reports. Plan and coordinate team effort to deliver documentation packages on time and with high quality. Analyzes and resolves outstanding issues in early to late stage MDI product development. Identifies and fills scientific and regulatory gaps. Applies sound knowledge in product specific guidelines and relevant regulatory monographs for metered dose inhaler (MDI) products. Identifies opportunities and initiates and follow through scientific investigations to support key decision making in product development. Selects components (valves, cans, actuators, dose counters, overwraps) for MDI development. Develops, troubleshoots, and optimizes MDI processes from lab to pilot scale. Assists in scale up and transfer of processes from pilot to exhibit and commercial scale. Maintains a state of readiness of the MDI process equipment by performing preventive maintenance, calibration or functional modification as necessary. Characterizes active pharmaceutical ingredients (APIs) for respiratory products using techniques such as particle size by laser diffraction, Karl Fischer (KF) moisture analysis, thermogravimetric analysis (TGA), and microcalorimetry. Additional tasks as required Qualifications - Skills & Requirements Familiarity with health and safety regulations and cGMP. Possesses strong interpersonal / oral and written communication skills and ability to work in a team environment. Experience in MDI processing from R&D / pilot scale. Exhibit or commercial MDI process experience preferred. Possesses strong understanding of fundamentals of inhalation products in general and MDI products in particular. Possesses strong understanding of ANDA product development program flows and able to generate high quality documentations to support ANDA filing. Experience in statistical design of experiments as applied to MDI formulation and processes is a plus.Excellent documentation generating skills in a GMP environment. Sound knowledge with product specific guidelines and relevant regulatory monographs for MDI products. Experience in MDI processing from R&D to pilot scale. Exhibit or commercial MDI process experience preferred. Excellent documentation generating skills in a GMP environment. Education & Experience BS degree in Chemistry, Engineering, Pharmaceutical Sciences, or related field with 8+ years’ experience, MS with 4+ years’ experience, or Ph.D. with 2+ years’ experience. Compensation Min USD $75,000.00/Yr. Max USD $80,000.00/Yr. Benefits Annual bonus • Medical and Rx Benefits: choice of four medical plans through Horizon. Rx is automatically provided with medical benefits • Dental Benefits with three dental plan options through CIGNA • Vision Plan with two plan options through VSP • Life Insurance, Basic Life and AD&D, and Supplemental Life Insurance • Disability Insurance, Voluntary Short-Term Disability, and State Disability • Long-Term Disability (LTD), State (short term) disability – where applicable • FSA (Flexible Spending Accounts) – Both Health Care & Dependent Care Available • HSA (Health Savings Account) • 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years • Employee Assistance Program (EAP) - 100% Confidential and 100% company paid • Critical Illness and Accidental Insurance • Legal and Identity Theft Insurance • Paid Time Off - Paid vacation, PTO, ten paid Holidays annually 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 No Additional Requirements 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.